Porta Camera Iic
FDA 510(k) K770753 · General Electric Co.
510(k) numberK770753
Submission
- Device name
- Porta Camera Iic
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- April 25, 1977
- Decision date
- May 10, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Porta Camera Iic cleared by the FDA?
Porta Camera Iic (K770753) received a 510(k) decision of Substantially Equivalent on May 10, 1977, 15 days after the submission was received.
What is the product code of K770753?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.