Woodlyn Classic Refractor, Phoroptor

FDA 510(k) K874900 · Woodlyn, Inc.

Substantially Equivalent

510(k) numberK874900

Submission

Device name
Woodlyn Classic Refractor, Phoroptor
Applicant
Woodlyn, Inc.
Arlington Heights, IL, US
Received
December 1, 1987
Decision date
December 23, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HKN – Refractor, Manual, Non-Powered, Including Phoropter
Device class
Class I (low risk)
Regulation
21 CFR 886.1770
Specialty
Ophthalmic

Other 510(k)s with product code HKN

510(k)DeviceApplicantDecision
K936205Comprehensive Phoropter, MDR-680HKN · Traditional Canon USA, Inc.09/28/1994SE
K782118Ful-VueHKN · Traditional American Optical Corp.01/26/1979SE

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K841765Woodlyn Standard Slit Lamp Hssl-StHLQ · Traditional 08/07/1984SE
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Questions and answers

When was Woodlyn Classic Refractor, Phoroptor cleared by the FDA?

Woodlyn Classic Refractor, Phoroptor (K874900) received a 510(k) decision of Substantially Equivalent on December 23, 1987, 22 days after the submission was received.

What is the product code of K874900?

The FDA product code is HKN – Refractor, Manual, Non-Powered, Including Phoropter, a Class I (low risk) device regulated under 21 CFR 886.1770.