The following data is part of a premarket notification filed by Dynatherm Medical, Inc. with the FDA for Vitalheat.
| Device ID | K040911 |
| 510k Number | K040911 |
| Device Name: | VITALHEAT |
| Classification | System, Thermal Regulating |
| Applicant | DYNATHERM MEDICAL, INC. 819 MITTEN RD., SUITE 42 Burlingame, CA 94010 |
| Contact | John R Kane |
| Correspondent | Denise Leung Klinker UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-08 |
| Decision Date | 2004-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851137008007 | K040911 | 000 |