Braemar Manufacturing, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 3 (1 Class I)
- 510(k) Clearances
- 3
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0708-2025 | Class I | Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac even | December 18, 2024 |
| Z-1460-2020 | Class II | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 551 | January 22, 2020 |
| Z-1459-2020 | Class II | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 551 | January 22, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K171410 | ePatch | January 4, 2018 |
| K153473 | Braemar Telemetry Patch System | July 22, 2016 |
| K130294 | BRAEMAR CARDIOKEY HOLTER RECORDER | October 16, 2013 |