The following data is part of a premarket notification filed by Inditherm Medical with the FDA for Inditherm Patient Warming System, Models Mecu1; Otm1; Otm2; Gtm1; Ptm1; Otb; Rb1.
| Device ID | K051419 |
| 510k Number | K051419 |
| Device Name: | INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 |
| Classification | System, Thermal Regulating |
| Applicant | INDITHERM MEDICAL 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 |
| Contact | M.w. (andy) Anderson |
| Correspondent | M.w. (andy) Anderson INDITHERM MEDICAL 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2006-04-27 |
| Summary: | summary |