FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BIEGLER BW385L BLOOD & INFUSION WARMER
K Number: K954769
·
Decision Aug 8, 1996
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
74
Applicant Total
1
Review Days
297
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Basic Information
- Device Name
- BIEGLER BW385L BLOOD & INFUSION WARMER
- K Number
- K954769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biegler Medical Products, Inc.
- Date Received
- October 16, 1995
- Decision Date
- August 8, 1996
- Product Code
- LGZ
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | FDA class 2 | General Hospital |
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