The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Hf1202h Powerplus Portable X-ray Equipment.
| Device ID | K153059 |
| 510k Number | K153059 |
| Device Name: | HF1202H PowerPlus Portable X-ray Equipment |
| Classification | System, X-ray, Mobile |
| Applicant | MINXRAY, INC. 3611 COMMERCIAL AVE. Northbrook, IL 60062 |
| Contact | Keith Kretchmer |
| Correspondent | Daniel Kamm Kamm & Associates 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-21 |
| Decision Date | 2016-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861050000323 | K153059 | 000 |
| 00858846007000 | K153059 | 000 |