The following data is part of a premarket notification filed by Aed Battery Exchange, Llc with the FDA for Extended Life Battery.
| Device ID | K120350 |
| 510k Number | K120350 |
| Device Name: | EXTENDED LIFE BATTERY |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | AED BATTERY EXCHANGE, LLC 1000 BROWN STREET SUITE 310 Wauconda, IL 60084 |
| Contact | Keith Hochhalter |
| Correspondent | Keith Hochhalter AED BATTERY EXCHANGE, LLC 1000 BROWN STREET SUITE 310 Wauconda, IL 60084 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865292000141 | K120350 | 000 |
| 00864312000260 | K120350 | 000 |
| 00864312000253 | K120350 | 000 |
| 00864312000246 | K120350 | 000 |
| 00864312000239 | K120350 | 000 |
| 00864312000222 | K120350 | 000 |
| 00864312000215 | K120350 | 000 |
| 00864312000208 | K120350 | 000 |