The following data is part of a premarket notification filed by Tempo Technology, Inc. with the FDA for Model 90p Portable Medical Diagnostic X-ray.
| Device ID | K934700 |
| 510k Number | K934700 |
| Device Name: | MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | TEMPO TECHNOLOGY, INC. 2090 W. DOWELL RD. Columbia City, IN 46725 |
| Contact | Christopher E Dare |
| Correspondent | Christopher E Dare TEMPO TECHNOLOGY, INC. 2090 W. DOWELL RD. Columbia City, IN 46725 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-30 |
| Decision Date | 1994-03-16 |
| Summary: | summary |