The following data is part of a premarket notification filed by Access / God Loves You with the FDA for Medical Battery Packs.
| Device ID | K922909 |
| 510k Number | K922909 |
| Device Name: | MEDICAL BATTERY PACKS |
| Classification | Pump, Infusion |
| Applicant | ACCESS / GOD LOVES YOU P.O. BOX 1630 Castle Rock, CO 80104 |
| Contact | Gwen Reed |
| Correspondent | Gwen Reed ACCESS / GOD LOVES YOU P.O. BOX 1630 Castle Rock, CO 80104 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-19 |
| Decision Date | 1992-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814314015243 | K922909 | 000 |
| 00814314011016 | K922909 | 000 |
| 00814314011023 | K922909 | 000 |
| 00814314011030 | K922909 | 000 |
| 00814314011061 | K922909 | 000 |
| 00814314011153 | K922909 | 000 |
| 00814314011252 | K922909 | 000 |
| 00814314011306 | K922909 | 000 |
| 00814314011320 | K922909 | 000 |
| 00814314011368 | K922909 | 000 |
| 00814314011597 | K922909 | 000 |
| 00814314011962 | K922909 | 000 |
| 00814314012747 | K922909 | 000 |
| 00814314013263 | K922909 | 000 |
| 00814314013324 | K922909 | 000 |
| 00814314014468 | K922909 | 000 |
| 00814314010255 | K922909 | 000 |