The following data is part of a premarket notification filed by Covidien with the FDA for Covidien Warmtouch Convective Warming Unit.
| Device ID | K123083 |
| 510k Number | K123083 |
| Device Name: | COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT |
| Classification | System, Thermal Regulating |
| Applicant | COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Contact | Stacey A Strand |
| Correspondent | Stacey A Strand COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521084599 | K123083 | 000 |
| 10884521084568 | K123083 | 000 |
| 10884521141100 | K123083 | 000 |
| 10884521190672 | K123083 | 000 |
| 10884521817517 | K123083 | 000 |
| 10884521084612 | K123083 | 000 |
| 10884521169227 | K123083 | 000 |
| 10884521817524 | K123083 | 000 |