Camera, Cleon 720 Large Field Gamma
FDA 510(k) K790081 · Union Carbide Corp.
510(k) numberK790081
Submission
- Device name
- Camera, Cleon 720 Large Field Gamma
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- January 12, 1979
- Decision date
- January 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Camera, Cleon 720 Large Field Gamma cleared by the FDA?
Camera, Cleon 720 Large Field Gamma (K790081) received a 510(k) decision of Substantially Equivalent on January 26, 1979, 14 days after the submission was received.
What is the product code of K790081?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.