FDA Registration
Active
🇺🇸 United States
ZOLL PROPAQ MD
Reg #: 3015997711
·
FEI: 3015997711
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- KATMAI INTEGRATED SOLUTIONS
- Registration Number
- 3015997711
- FEI Number
- 3015997711
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 34 Kelley Way
- City
- Brilliant
- State
- OH
- ZIP
- 43913
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100654
Owner / Operator
- Firm Name
- Katmai Health Services, LLC
- Operator Number
- 10050389
- Address
- 701 E. Tudor Rd., Suite 215
- City
- Anchorage
- State
- AK
- Postal Code
- 99503
- Country
- US
- Correspondent
- Lisa Talkington
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2016-04-08 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2016-04-08 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2016-04-08 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2016-04-08 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2016-04-08 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2016-04-08 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2016-04-08 |
Proprietary Names
ZOLL PROPAQ MD
Establishment Types
Repack or Relabel Medical Device