The following data is part of a premarket notification filed by Amco International Manufacturing & Design, Inc. with the FDA for Life+cel Or Lifecel Battery.
| Device ID | K073716 |
| 510k Number | K073716 |
| Device Name: | LIFE+CEL OR LIFECEL BATTERY |
| Classification | Automated External Defibrillators (non-wearable) |
| 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 | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853258006047 | K073716 | 000 |