The following data is part of a premarket notification filed by Access Battery, Inc. with the FDA for Battery, Rechargeable.
| Device ID | K030261 |
| 510k Number | K030261 |
| Device Name: | BATTERY, RECHARGEABLE |
| Classification | System, Monitoring, Perinatal |
| 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 | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-24 |
| Decision Date | 2003-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814314011788 | K030261 | 000 |
| 00814314011733 | K030261 | 000 |