The following data is part of a premarket notification filed by Vitaheat Medical, Llc with the FDA for Vitaheat Patient Warming System.
| Device ID | K132454 |
| 510k Number | K132454 |
| Device Name: | VITAHEAT PATIENT WARMING SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | VITAHEAT MEDICAL, LLC 1585 BEVERLY DR. #121 Aurora, IL 60502 |
| Contact | Jack Slovick |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-08-06 |
| Decision Date | 2013-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851446007142 | K132454 | 000 |
| 00851446007012 | K132454 | 000 |
| 00851446007036 | K132454 | 000 |
| 00851446007043 | K132454 | 000 |
| 00851446007067 | K132454 | 000 |
| 00851446007081 | K132454 | 000 |
| 00851446007098 | K132454 | 000 |
| 00851446007104 | K132454 | 000 |
| 00851446007128 | K132454 | 000 |
| 00851446007005 | K132454 | 000 |