Monitor, Patient, Resp. Carbon Dioxide
FDA 510(k) K770713 · Cavitron Corp.
510(k) numberK770713
Submission
- Device name
- Monitor, Patient, Resp. Carbon Dioxide
- Applicant
- Cavitron Corp.
Mchenry, IL, US - Received
- April 18, 1977
- Decision date
- April 27, 1977
- 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 Monitor, Patient, Resp. Carbon Dioxide cleared by the FDA?
Monitor, Patient, Resp. Carbon Dioxide (K770713) received a 510(k) decision of Substantially Equivalent on April 27, 1977, 9 days after the submission was received.
What is the product code of K770713?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.