FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
K Number: K053645
·
Decision Mar 9, 2006
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
6
Review Days
69
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
- K Number
- K053645
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arizant Healthcare, Inc.
- Date Received
- December 30, 2005
- Decision Date
- March 9, 2006
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWJ), ordered by most recent decision date.
Hot Pink Pad Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Temperature Management System (Model 5000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Celsi Warmer
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Stat Temperature Management System
FDA 510(k)
FDA Class 2
·Cardiovascular
HotDog Warming Mattress + Return Electrode
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Arizant Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120412 | 3M SPOTON TEMPERATURE MONITORING SYSTEM | May 30, 2012 | Substantially Equivalent |
| K082217 | RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM | Oct 6, 2008 | Substantially Equivalent |
| K060939 | RANGER IRRIGATION FLUID WARMING SYSTEM | Jun 26, 2006 | Substantially Equivalent |
| K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 | Apr 24, 2006 | Substantially Equivalent |
| K041686 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM | Jun 30, 2004 | Substantially Equivalent |