Model IM1074 End-Tidal CO2 Module
FDA 510(k) K843970 · Gould, Inc.
510(k) numberK843970
Submission
- Device name
- Model IM1074 End-Tidal CO2 Module
- Applicant
- Gould, Inc.
Walker, MI, US - Received
- October 11, 1984
- Decision date
- October 24, 1984
- 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 Model IM1074 End-Tidal CO2 Module cleared by the FDA?
Model IM1074 End-Tidal CO2 Module (K843970) received a 510(k) decision of Substantially Equivalent on October 24, 1984, 13 days after the submission was received.
What is the product code of K843970?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.