BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER— 510(k) K072008
Substantially EquivalentBraemar, Inc.
FDA 510(k) clearance K072008 for BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER, Substantially Equivalent on 2007-10-03. Applicant: Braemar, Inc.. Device class: 2.
Clearance details
- Applicant
- Braemar, Inc.
- Product code
- Code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eagan, MN, US
Recent devices under product code DRG
view allMore clearances from Braemar, Inc.
view allAdverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K072008
K-number listed on FDA's recall record- Z-1652-2013 — Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
- Z-1645-2013 — Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072008.
Data sourced from openFDA. This site is unofficial and independent of the FDA.