MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
FDA 510(k) clearance K053645 · decided 2006-03-09
Clearance details
- K-number
- K053645
- Device name
- MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
- Applicant
- Arizant Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-30
- Decision date
- 2006-03-09
- Days to decision
- 69 days
- Clearance type
- Special
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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