BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
FDA 510(k) clearance K072008 · decided 2007-10-03
Clearance details
- K-number
- K072008
- Device name
- BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
- Applicant
- Braemar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-23
- Decision date
- 2007-10-03
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- DRG
- Device class
- 2
- Regulation number
- 870.2910
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eagan, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Braemar
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UbiqVue™ 2AYe Cardiac System (UX2253) (K261569) | Lifesignals, Inc. | 2026-07-09 |
| Perin Health System (PHD80060-2) (K252984) | Perin Health Devices, LLC | 2026-01-22 |
| EasyTeleMed (2.0.2) (K252440) | Ingeniars S.R.L. | 2025-10-02 |
| TeleRehab Aermos Cardiopulmonary Rehabilitation (K250259) | The ScottCare Corporation | 2025-06-04 |
| iBSM (K243837) | Iorbit Digital Technologies Private Limited | 2025-05-16 |
| UbiqVue™ 2A Multi-parameter System (UX2550) (K242018) | Lifesignals, Inc. | 2024-11-12 |
| BioButton System (K241101) | Biointellisense, Inc. | 2024-09-26 |
| ANNE Chest (K240251) | Sibel Health, Inc. | 2024-06-03 |
| ANNE One (K223711) | Sibel Health, Inc. | 2023-08-10 |
| HD+12, HD+15 (K220526) | Cardioline S.P.A | 2023-05-15 |
| Alio (K223073) | Alio, Inc. | 2023-03-17 |
| Care Team Portal (K222398) | Vivify Health, Inc. | 2023-02-06 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 W recall (Z-1645-2013) | BRAEMAR, INC. | 2013-07-02 |
| Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 W recall (Z-1652-2013) | BRAEMAR, INC. | 2013-07-02 |