Ocular-Biometer 4000
FDA 510(k) K820042 · Radionics, Inc.
510(k) numberK820042
Submission
- Device name
- Ocular-Biometer 4000
- Applicant
- Radionics, Inc.
Walker, MI, US - Received
- January 7, 1982
- Decision date
- July 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Ocular-Biometer 4000 cleared by the FDA?
Ocular-Biometer 4000 (K820042) received a 510(k) decision of Substantially Equivalent on July 22, 1982, 196 days after the submission was received.
What is the product code of K820042?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.