CPM Metabolic Monitor
FDA 510(k) K823695 · Medicor USA , Ltd.
510(k) numberK823695
Submission
- Device name
- CPM Metabolic Monitor
- Applicant
- Medicor USA , Ltd.
Mchenry, IL, US - Received
- December 8, 1982
- Decision date
- January 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZL – Computer, Oxygen-Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1730
- Specialty
- Anesthesiology
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Questions and answers
When was CPM Metabolic Monitor cleared by the FDA?
CPM Metabolic Monitor (K823695) received a 510(k) decision of Substantially Equivalent on January 14, 1983, 37 days after the submission was received.
What is the product code of K823695?
The FDA product code is BZL – Computer, Oxygen-Uptake, a Class II (moderate risk) device regulated under 21 CFR 868.1730.