EXTENDED LIFE BATTERY
FDA 510(k) clearance K120350 · decided 2012-11-01
Clearance details
- K-number
- K120350
- Device name
- EXTENDED LIFE BATTERY
- Applicant
- Aed Battery Exchange, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-02-06
- Decision date
- 2012-11-01
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wauconda, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DBP-1400-ABE and DBP-2003- ABE (P190013/S001) | Aed Battery Exchange, LLC | 2025-10-28 |
| AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) (P190013) | Aed Battery Exchange, LLC | 2021-02-02 |