The following data is part of a premarket notification filed by Access / God Loves You with the FDA for Medical Battery Packs.
| Device ID | K922910 |
| 510k Number | K922910 |
| Device Name: | MEDICAL BATTERY PACKS |
| Classification | Ophthalmoscope, Battery-powered |
| 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 | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-19 |
| Decision Date | 1992-09-30 |