The following data is part of a premarket notification filed by Health Care Mfg., Inc. with the FDA for Hcmi X-ray.
| Device ID | K022667 |
| 510k Number | K022667 |
| Device Name: | HCMI X-RAY |
| Classification | System, X-ray, Stationary |
| Applicant | HEALTH CARE MFG., INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm HEALTH CARE MFG., INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-12 |
| Decision Date | 2002-10-22 |
| Summary: | summary |