The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Minxray, Model Hf100h+.
| Device ID | K052721 |
| 510k Number | K052721 |
| Device Name: | MINXRAY, MODEL HF100H+ |
| Classification | System, X-ray, Mobile |
| Applicant | MINXRAY, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MINXRAY, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2005-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861050000316 | K052721 | 000 |
| 00858846007017 | K052721 | 000 |