Tidal Wave Carbon Dioxide Monitor, Model 610
FDA 510(k) K963327 · Novametrix Medical Systems, Inc.
510(k) numberK963327
Submission
- Device name
- Tidal Wave Carbon Dioxide Monitor, Model 610
- Applicant
- Novametrix Medical Systems, Inc.
Wallingford, CT, US - Received
- August 23, 1996
- Decision date
- November 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Tidal Wave Carbon Dioxide Monitor, Model 610 cleared by the FDA?
Tidal Wave Carbon Dioxide Monitor, Model 610 (K963327) received a 510(k) decision of Substantially Equivalent on November 20, 1996, 89 days after the submission was received.
What is the product code of K963327?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.