The following data is part of a premarket notification filed by Amco International Manufacturing & Design, Inc. with the FDA for Amco Replacement Battery For Philips Medical Models Bt1 And M5070a.
| Device ID | K091548 |
| 510k Number | K091548 |
| Device Name: | AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. 377 ZANE COURT Elizabeth, CO 80107 |
| Contact | Alexander B Henderson |
| Correspondent | Alexander B Henderson AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. 377 ZANE COURT 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 | 2009-05-27 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853258006061 | K091548 | 000 |
| 00853258006054 | K091548 | 000 |