FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAIR HUGGER MODEL 600 UNIT, BLANKETS
K Number: K950416
·
Decision Aug 29, 1995
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
154
Applicant Total
25
Review Days
210
Basic Information
- Device Name
- BAIR HUGGER MODEL 600 UNIT, BLANKETS
- K Number
- K950416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AUGUSTINE MEDICAL, INC.
- Date Received
- January 31, 1995
- Decision Date
- August 29, 1995
- 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 |
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Other Clearances by AUGUSTINE MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K021473 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM | Jul 9, 2002 | Substantially Equivalent |
| K020077 | MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX | Jan 31, 2002 | Substantially Equivalent |
| K001149 | AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK | Sep 6, 2000 | Substantially Equivalent |
| K973741 | BAIR HUGGER BLOOD/FLUID WARMER | Apr 30, 1998 | Substantially Equivalent |
| K964673 | BAIR HUGGER MODEL 630 CARDIAC BLANKET | Jun 26, 1997 | Substantially Equivalent |
| K963293 | AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX | Mar 28, 1997 | Substantially Equivalent for Some Indications |
| K963672 | MODEL 90022 ROLLING STAND | Jan 6, 1997 | Substantially Equivalent |
| K960167 | SYSTEM, THERMAL REGULATING 74-DWJ | Jun 17, 1996 | Substantially Equivalent |
| K954446 | AUGUSTINE INTUBATION GUIDE | Dec 29, 1995 | Substantially Equivalent |
| K952864 | BAIR HUGGER MODEL 655 BLANKET | Sep 12, 1995 | Substantially Equivalent |