Nidek US-2500 W/Biometry Unit US-2520
FDA 510(k) K902411 · Nidek, Inc.
510(k) numberK902411
Submission
- Device name
- Nidek US-2500 W/Biometry Unit US-2520
- Applicant
- Nidek, Inc.
Palo Alto, CA, US - Received
- May 31, 1990
- Decision date
- October 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Nidek US-2500 W/Biometry Unit US-2520 cleared by the FDA?
Nidek US-2500 W/Biometry Unit US-2520 (K902411) received a 510(k) decision of Substantially Equivalent on October 9, 1990, 131 days after the submission was received.
What is the product code of K902411?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.