FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAIR HUGGER BLOOD/FLUID WARMER
K Number: K973741
·
Decision Apr 30, 1998
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
13
Applicant Total
25
Review Days
211
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Basic Information
- Device Name
- BAIR HUGGER BLOOD/FLUID WARMER
- K Number
- K973741
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9205
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Augustine Medical, Inc.
- Date Received
- October 1, 1997
- Decision Date
- April 30, 1998
- Product Code
- BSB
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | FDA class 2 | Hematology |
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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 |
| 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 |
| K950416 | BAIR HUGGER MODEL 600 UNIT, BLANKETS | Aug 29, 1995 | Substantially Equivalent |