FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM
K Number: K933726
·
Decision Jan 28, 1994
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
23
Applicant Total
25
Review Days
179
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 OF BAIR HUGGER PATIENT WARMING SYSTEM
- K Number
- K933726
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5950
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Augustine Medical, Inc.
- Date Received
- August 2, 1993
- Decision Date
- January 28, 1994
- Product Code
- LHC
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LHC | Warmer, Irrigation Solution | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHC), ordered by most recent decision date.
Getinge Series Warming Cabinet
FDA 510(k)
FDA Class 1
·Physical Medicine
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
FDA 510(k)
FDA Class 1
·Physical Medicine
IntraTemp Solution Warmer
FDA 510(k)
FDA Class 1
·Physical Medicine
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
FDA 510(k)
FDA Class 1
·Physical Medicine
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
FDA 510(k)
FDA Class 1
·Physical Medicine
INTRATEMP SOLUTION WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
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 |