FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPM METABOLIC MONITOR
K Number: K823695
·
Decision Jan 14, 1983
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
14
Review Days
37
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Basic Information
- Device Name
- CPM METABOLIC MONITOR
- K Number
- K823695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medicor USA , Ltd.
- Date Received
- December 8, 1982
- Decision Date
- January 14, 1983
- Product Code
- BZL
- 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 |
|---|---|---|---|
| BZL | Computer, Oxygen-Uptake | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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