The following data is part of a premarket notification filed by Promedtek, Inc. with the FDA for Model Pmt850.
| Device ID | K070931 |
| 510k Number | K070931 |
| Device Name: | MODEL PMT850 |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | PROMEDTEK, INC. 1220 19TH ST., NW SUITE 300 Washington, DC 20036 |
| Contact | Diane Mandell |
| Correspondent | Diane Mandell PROMEDTEK, INC. 1220 19TH ST., NW SUITE 300 Washington, DC 20036 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-03 |
| Decision Date | 2007-05-24 |
| Summary: | summary |