FDA Registration
Active
🇵🇱 Poland
IntelliVue NMT Hand-Adapter
Reg #: 3017935637
·
FEI: 3017935637
·
Expires 2025
Products
39
Proprietary Names
1
Establishment Types
1
Classifications
39
Registration Details
- Registration Name
- TOPSIL SP. Z O.O. SP.K
- Registration Number
- 3017935637
- FEI Number
- 3017935637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Graniczna 6 street
- City
- Slubica B Mazowieckie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K122439
Owner / Operator
- Firm Name
- Topsil Sp. z o.o. Sp.K
- Operator Number
- 10079665
- Address
- Graniczna 6 street
- City
- S?ubica B
- State
- Mazowieckie
- Postal Code
- 96-321
- Country
- PL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2021-01-11 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2021-01-11 |
| Monitor, St Segment | MLC | Class 2 | Cardiovascular | No | 2021-01-11 |
| Tester, Electrode, Surface, Electrocardiographic | KRC | Class 2 | Cardiovascular | No | 2021-01-11 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2021-01-11 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2021-01-11 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2021-01-11 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2021-01-11 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2021-01-11 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2021-01-11 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2021-01-11 |
| System, Signal Isolation | DRJ | Class 1 | Cardiovascular | No | 2021-01-11 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2021-01-11 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-01-11 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2021-01-11 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2021-01-11 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2021-01-11 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-01-11 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2021-01-11 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2021-01-11 |
| Monitor, Carbon-Dioxide, Cutaneous | LKD | Class 2 | Anesthesiology | No | 2021-01-11 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2021-01-11 |
| Adaptor, Lead Switching, Electrocardiograph | DRW | Class 2 | Cardiovascular | No | 2021-01-11 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2021-01-11 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2021-01-11 |
| Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK | Class 2 | Anesthesiology | No | 2021-01-11 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2021-01-11 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2021-01-11 |
| Generator, Electroencephalograph Test Signal | GWR | Class 1 | Neurology | No | 2021-01-11 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2021-01-11 |
| Analyzer, Spectrum, Electroencephalogram Signal | GWS | Class 1 | Neurology | No | 2021-01-11 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-01-11 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2021-01-11 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2021-01-11 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2021-01-11 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2021-01-11 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2021-01-11 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2021-01-11 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2021-01-11 |
Proprietary Names
IntelliVue NMT Hand-Adapter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)