Cilco Sonometrics Digicon
FDA 510(k) K854653 · CooperVision, Inc.
510(k) numberK854653
Submission
- Device name
- Cilco Sonometrics Digicon
- Applicant
- CooperVision, Inc.
Irvine, CA, US - Received
- November 19, 1985
- Decision date
- September 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Cilco Sonometrics Digicon cleared by the FDA?
Cilco Sonometrics Digicon (K854653) received a 510(k) decision of Substantially Equivalent on September 4, 1986, 289 days after the submission was received.
What is the product code of K854653?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.