Volumetric Package Stepper H4222AA/CALCU. H4222AB
FDA 510(k) K872307 · General Electric Co.
510(k) numberK872307
Submission
- Device name
- Volumetric Package Stepper H4222AA/CALCU. H4222AB
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- June 16, 1987
- Decision date
- September 8, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Volumetric Package Stepper H4222AA/CALCU. H4222AB cleared by the FDA?
Volumetric Package Stepper H4222AA/CALCU. H4222AB (K872307) received a 510(k) decision of Substantially Equivalent on September 8, 1987, 84 days after the submission was received.
What is the product code of K872307?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.