FDA Registration
Active
🇦🇺 Australia
Lifepak
Reg #: 3010703925
·
FEI: 3010703925
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- MAKAR CONSULTING PTY LTD
- Registration Number
- 3010703925
- FEI Number
- 3010703925
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Garigal Road
- City
- Belrose New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K082937
Owner / Operator
- Firm Name
- Makar Consulting Pty Ltd
- Operator Number
- 10062928
- Address
- 1 Garigal Road
- City
- Belrose
- State
- New South Wales
- Postal Code
- 2085
- Country
- AU
- Correspondent
- Richard J Blunden
US Agent
- Business Name
- Vomark Technologies, Inc
- Contact Name
- Peter Pekalski
- Address
- 406 Diens Drive
- City
- Wheeling
- State
- IL
- ZIP
- 60090
- Country
- US
- [email protected]
- Phone
- 312 2539892
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-09-08 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-09-08 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2023-09-08 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2023-09-08 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2023-09-08 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-09-08 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2023-09-08 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2023-09-08 |
Proprietary Names
Lifepak
Establishment Types
Export Device to the United States But Perform No Other Operation on Device