MRM-2 Oxygen Consumption Monitor
FDA 510(k) K801852 · Waters Assoc., Inc.
510(k) numberK801852
Submission
- Device name
- MRM-2 Oxygen Consumption Monitor
- Applicant
- Waters Assoc., Inc.
Mchenry, IL, US - Received
- August 4, 1980
- Decision date
- August 20, 1980
- 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 MRM-2 Oxygen Consumption Monitor cleared by the FDA?
MRM-2 Oxygen Consumption Monitor (K801852) received a 510(k) decision of Substantially Equivalent on August 20, 1980, 16 days after the submission was received.
What is the product code of K801852?
The FDA product code is BZL – Computer, Oxygen-Uptake, a Class II (moderate risk) device regulated under 21 CFR 868.1730.