Starcam 4000
FDA 510(k) K904174 · General Electric Co.
510(k) numberK904174
Submission
- Device name
- Starcam 4000
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- September 10, 1990
- Decision date
- January 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Starcam 4000 cleared by the FDA?
Starcam 4000 (K904174) received a 510(k) decision of Substantially Equivalent on January 4, 1991, 116 days after the submission was received.
What is the product code of K904174?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.