The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R&d Batteries, Part Nos. 5135, 5097, 5444, And 5502.
| Device ID | K942034 |
| 510k Number | K942034 |
| Device Name: | R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502 |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville, MN 55337 |
| Contact | Randall C Noddings |
| Correspondent | Randall C Noddings R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville, MN 55337 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-28 |
| Decision Date | 1994-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810149094644 | K942034 | 000 |
| 00810149090745 | K942034 | 000 |
| 00810149090837 | K942034 | 000 |
| 00810149091056 | K942034 | 000 |
| 00810149091148 | K942034 | 000 |
| 00810149092039 | K942034 | 000 |
| 00810149093630 | K942034 | 000 |
| 00810149093647 | K942034 | 000 |
| 00810149094637 | K942034 | 000 |
| 00810149090684 | K942034 | 000 |