The following data is part of a premarket notification filed by Qmax Medical, Inc. with the FDA for Q-scan Thermography System.
| Device ID | K843124 |
| 510k Number | K843124 |
| Device Name: | Q-SCAN THERMOGRAPHY SYSTEM |
| Classification | System, Thermographic, Liquid Crystal, Powered (adjunctive Use) |
| Applicant | QMAX MEDICAL, INC. P.O. BOX 1181 Dayton , OH 45401 - |
| Contact | Julian M Mendoza |
| Correspondent | Julian M Mendoza QMAX MEDICAL, INC. P.O. BOX 1181 Dayton , OH 45401 - |
| Product Code | KXZ |
| CFR Regulation Number | 884.2982 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-08 |
| Decision Date | 1984-11-29 |