The following data is part of a premarket notification filed by Arizant Healthcare Inc. with the FDA for Modification To:bair Hugger Temperature Management Systems.
| Device ID | K053645 |
| 510k Number | K053645 |
| Device Name: | MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS |
| Classification | System, Thermal Regulating |
| Applicant | ARIZANT HEALTHCARE INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Contact | David Westlin |
| Correspondent | David Westlin ARIZANT HEALTHCARE INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-30 |
| Decision Date | 2006-03-09 |
| Summary: | summary |