Co 2 Meter
FDA 510(k) K792155 · Boehringer Laboratories
510(k) numberK792155
Submission
- Device name
- Co 2 Meter
- Applicant
- Boehringer Laboratories
Mchenry, IL, US - Received
- October 24, 1979
- Decision date
- November 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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Questions and answers
When was Co 2 Meter cleared by the FDA?
Co 2 Meter (K792155) received a 510(k) decision of Substantially Equivalent on November 27, 1979, 34 days after the submission was received.
What is the product code of K792155?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.