GF-310R Multigas Unit (GF-310R)
FDA 510(k) K251641 · Nihon Kohden Corporation
510(k) numberK251641
Submission
- Device name
- GF-310R Multigas Unit (GF-310R)
- Applicant
- Nihon Kohden Corporation
Tokyo, JP - Received
- May 29, 2025
- Decision date
- August 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 GF-310R Multigas Unit (GF-310R) cleared by the FDA?
GF-310R Multigas Unit (GF-310R) (K251641) received a 510(k) decision of Substantially Equivalent on August 12, 2026, 440 days after the submission was received.
What is the product code of K251641?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.