FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTEMP
K Number: K896018
·
Decision Feb 9, 1990
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
71
Applicant Total
3
Review Days
116
Basic Information
- Device Name
- BIOTEMP
- K Number
- K896018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- MEDADVANCES, INC.
- Date Received
- October 16, 1989
- Decision Date
- February 9, 1990
- 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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