The following data is part of a premarket notification filed by Access Battery, Inc. with the FDA for Battery Pack, Rechargeable, Models Mla0051, Mla90479, Mnc5169l/p, Mnc1000ekg, Mnc14649p.
| Device ID | K032051 |
| 510k Number | K032051 |
| Device Name: | BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ACCESS BATTERY, INC. 5357 HIGHWAY 86 Elizabeth, CO 80107 |
| Contact | Alexander B Henderson |
| Correspondent | Alexander B Henderson ACCESS BATTERY, INC. 5357 HIGHWAY 86 Elizabeth, CO 80107 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-02 |
| Decision Date | 2004-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814314012471 | K032051 | 000 |
| 00814314011634 | K032051 | 000 |
| 00814314011627 | K032051 | 000 |
| 00814314011573 | K032051 | 000 |
| 00814314011542 | K032051 | 000 |
| 00814314011399 | K032051 | 000 |
| 00814314011238 | K032051 | 000 |
| 00814314011177 | K032051 | 000 |
| 00814314011160 | K032051 | 000 |
| 00814314011047 | K032051 | 000 |
| 00814314010200 | K032051 | 000 |
| 00814314011818 | K032051 | 000 |
| 00814314011870 | K032051 | 000 |
| 00814314011429 | K032051 | 000 |
| 00814314011412 | K032051 | 000 |
| 00814314011245 | K032051 | 000 |
| 00814314011207 | K032051 | 000 |
| 00814314012020 | K032051 | 000 |
| 00814314015182 | K032051 | 000 |
| 00814314014727 | K032051 | 000 |
| 00814314014611 | K032051 | 000 |
| 00814314012518 | K032051 | 000 |
| 00814314012280 | K032051 | 000 |
| 00814314010132 | K032051 | 000 |