The following data is part of a premarket notification filed by Inditherm Medical with the FDA for Cosytherm, Models Ncm1, Ncm2, Ncb1, Ccu1, Cru1.
| Device ID | K061902 |
| 510k Number | K061902 |
| Device Name: | COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 |
| 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 | 2006-07-05 |
| Decision Date | 2006-12-08 |
| Summary: | summary |