FDA Registration
Active
🇺🇸 United States
PHYSIO-CONTROL, INC.
Reg #: 3015876
·
FEI: 3015876
·
Expires 2026
Products
14
Proprietary Names
32
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- PHYSIO-CONTROL, INC.
- Registration Number
- 3015876
- FEI Number
- 3015876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 11811 WILLOWS RD., N.E.
- City
- Redmond
- State
- WA
- ZIP
- 98052
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142430
- PMA Number
- P190007
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2020-12-08 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2017-11-13 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2017-11-13 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2017-11-13 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-11-13 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2017-11-13 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2017-11-13 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2017-11-13 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2017-11-13 |
| Compressor, Cardiac, External | DRM | Class 2 | Cardiovascular | No | 2018-02-14 |
| Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator | MPD | Class 2 | Cardiovascular | No | 2024-05-16 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2024-10-23 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2024-05-16 |
| Prep Kit | PXD | Class 1 | General Hospital | No | 2022-12-20 |
Proprietary Names
QUIK-COMBO RTS pacing/defibrillation/ECG electrodes
QUIK-COMBO pacing/defibrillation/ECG electrodes
QUIK-COMBO RTS Pediatric pacing/defibrillation/ECG electrodes
QUIK-COMBO pacing/defibrillation/ECG electrodes with REDI-PAK preconnected system
LIFEPAK FLEX Battery Charger
LIFEPAK Temperature Adapter Cable
LIFEPAK® 35 AC Power Adapter
LIFEPAK Printer Kit
LIFEPAK Printer Cable
LIFEPAK® Invasive Pressure Adapter Cable
LIFEPAK EXPRESS
LIFEPAK CR Plus
Prep Kit
LUCAS Power Supply with Cord
LUCAS Car Cable 12V
LUCAS 2 Battery
LUCAS 2
LUCAS Battery Charger with Cord
LUCAS PCI Back Plate
LUCAS Back Plate Grip Tape
LUCAS 3
LUCAS BATTERY, DARK GRAY
LUCAS ANTI SLIP, SLIM BACK PLATE
LIFEPAK 1000
LIFEPAK 20
LIFEPAK 15
LIFEPAK 35
LIFEPAK 20E
LIFEPAK 15 AC Power Adapter
LIFEPAK® ECG Cables
LIFEPAK CR2
Sterilizable Internal Defibrillation Paddles
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device