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 |