FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONITEMP BLOOD PACK TEMP. MONITOR
K Number: K800667
·
Decision Apr 16, 1980
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
3
Applicant Total
3
Review Days
21
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Basic Information
- Device Name
- MONITEMP BLOOD PACK TEMP. MONITOR
- K Number
- K800667
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9700
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Liquid Crystal Products, Inc.
- Date Received
- March 26, 1980
- Decision Date
- April 16, 1980
- Product Code
- KSE
- 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 |
|---|---|---|---|
| KSE | Refrigerator, Freezer, Blood Storage | FDA class 2 | Hematology |
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