The following data is part of a premarket notification filed by Arizant Healthcare Inc. with the FDA for Bair Paws Temperature Management System Model 850.
Device ID | K060865 |
510k Number | K060865 |
Device Name: | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 |
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 | 2006-03-30 |
Decision Date | 2006-04-24 |
Summary: | summary |