The following data is part of a premarket notification filed by Amco International Manufacturing & Design, Inc. with the FDA for Life+cel Battery.
| Device ID | K071164 |
| 510k Number | K071164 |
| Device Name: | LIFE+CEL BATTERY |
| Classification | Batteries, Rechargeable, For Class 3 Devices |
| Applicant | AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. 377 ZANE COURT HILLSIDE VILLAGE Elizabeth, CO 80107 |
| Contact | Alex Henderson |
| Correspondent | Alex Henderson AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. 377 ZANE COURT HILLSIDE VILLAGE Elizabeth, CO 80107 |
| Product Code | MOY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-26 |
| Decision Date | 2007-12-07 |
| Summary: | summary |