Nidek Handy

FDA 510(k) K973218 · Nidek, Inc.

Substantially Equivalent

510(k) numberK973218

Submission

Device name
Nidek Handy
Applicant
Nidek, Inc.
Fremont, CA, US
Received
August 27, 1997
Decision date
November 4, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HKI – Camera, Ophthalmic, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1120
Specialty
Ophthalmic

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Questions and answers

When was Nidek Handy cleared by the FDA?

Nidek Handy (K973218) received a 510(k) decision of Substantially Equivalent on November 4, 1997, 69 days after the submission was received.

What is the product code of K973218?

The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.