Pocket Ultrasonic Pachymeter
FDA 510(k) K993674 · Quantel Medical
510(k) numberK993674
Submission
- Device name
- Pocket Ultrasonic Pachymeter
- Applicant
- Quantel Medical
Hasbrouck Heights, NJ, US - Received
- November 1, 1999
- Decision date
- July 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Pocket Ultrasonic Pachymeter cleared by the FDA?
Pocket Ultrasonic Pachymeter (K993674) received a 510(k) decision of Substantially Equivalent on July 13, 2000, 255 days after the submission was received.
What is the product code of K993674?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.