Pachymeter System V
FDA 510(k) K864336 · CooperVision, Inc.
510(k) numberK864336
Submission
- Device name
- Pachymeter System V
- Applicant
- CooperVision, Inc.
Bellevue, WA, US - Received
- November 4, 1986
- Decision date
- January 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Pachymeter System V cleared by the FDA?
Pachymeter System V (K864336) received a 510(k) decision of Substantially Equivalent on January 9, 1987, 66 days after the submission was received.
What is the product code of K864336?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.