FDA Registration
Active
🇺🇸 United States
Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A)
Reg #: 3016701404
·
FEI: 3016701404
·
Expires 2025
Products
20
Proprietary Names
14
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- Philips North America LLC
- Registration Number
- 3016701404
- FEI Number
- 3016701404
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1003 Corporate Lane, STE B
- City
- Export
- State
- PA
- ZIP
- 15632
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140535
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2014-12-01 |
| Monitor, Uterine Contraction, External (For Use In Clinic) | HFM | Class 2 | Obstetrics/Gynecology | No | 2014-12-01 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2014-12-01 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2014-12-01 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2014-12-01 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2014-12-01 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2014-12-01 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2014-12-01 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2014-12-01 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2014-12-01 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2014-12-01 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2014-12-01 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2014-12-01 |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | Class 2 | Cardiovascular | No | 2014-12-01 |
| Transducer, Ultrasonic, Obstetric | HGL | Class 2 | Obstetrics/Gynecology | No | 2014-12-01 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2014-12-01 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2014-12-01 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2014-12-01 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2014-12-01 |
| Transducer, Pressure, Intrauterine | HFN | Class 2 | Obstetrics/Gynecology | No | 2014-12-01 |
Proprietary Names
Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A)
Avalon Fetal & Maternal Patch
Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)
Avalon Patient Module (M2738A)
Avalon CL Fetal & Maternal Pod (866488)
M2734B
989803184851- Avalon Belt Clip
Remote Event Marker (989803143411)
Avalon Basestation (866074)
MECG Adapter Cable (M1363A)
M1913J Fetal Monitoring Recording Paper
M1911A Fetal Monitoring Recording Paper
M1913A Fetal Monitoring Recording Paper
M1910A Fetal Monitoring Recording Paper
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)