FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUGUSTINE INTUBATION GUIDE
K Number: K954446
·
Decision Dec 29, 1995
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
25
Review Days
95
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Basic Information
- Device Name
- AUGUSTINE INTUBATION GUIDE
- K Number
- K954446
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Augustine Medical, Inc.
- Date Received
- September 25, 1995
- Decision Date
- December 29, 1995
- Product Code
- CCW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| 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 |
| K952864 | BAIR HUGGER MODEL 655 BLANKET | Sep 12, 1995 | Substantially Equivalent |
| K950416 | BAIR HUGGER MODEL 600 UNIT, BLANKETS | Aug 29, 1995 | Substantially Equivalent |