The following data is part of a premarket notification filed by H.l. Lyons Co. with the FDA for Model H170 Pediatric Chest X-ray Unit.
| Device ID | K915667 |
| 510k Number | K915667 |
| Device Name: | MODEL H170 PEDIATRIC CHEST X-RAY UNIT |
| Classification | Holder, Radiographic Cassette, Wall-mounted |
| Applicant | H.L. LYONS CO. 11401 ELECTRON DR. LOUISVILLE, KY 40299 |
| Contact | LYONS |
| Correspondent | LYONS H.L. LYONS CO. 11401 ELECTRON DR. LOUISVILLE, KY 40299 |
| Product Code | IXY |
| CFR Regulation Number | 892.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-18 |
| Decision Date | 1992-01-31 |