Patient Gas Sampling Line for Ohmeda 6000
FDA 510(k) K910509 · Intertech Resources, Inc.
510(k) numberK910509
Submission
- Device name
- Patient Gas Sampling Line for Ohmeda 6000
- Applicant
- Intertech Resources, Inc.
Fort Myers, FL, US - Received
- February 5, 1991
- Decision date
- April 17, 1991
- 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 Patient Gas Sampling Line for Ohmeda 6000 cleared by the FDA?
Patient Gas Sampling Line for Ohmeda 6000 (K910509) received a 510(k) decision of Substantially Equivalent on April 17, 1991, 71 days after the submission was received.
What is the product code of K910509?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.