Skiascopic Racks

FDA 510(k) K844364 · Luneau Laboratories

Substantially Equivalent

510(k) numberK844364

Submission

Device name
Skiascopic Racks
Applicant
Luneau Laboratories
Walker, MI, US
Received
November 13, 1984
Decision date
January 2, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HMH – Rack, Skiascopic
Device class
Class I (low risk)
Regulation
21 CFR 886.1750
Specialty
Ophthalmic

Other 510(k)s with product code HMH

510(k)DeviceApplicantDecision
K843195Visitec Flieringa-Legrand Fixation RingHMH · Traditional Visitec Co.10/05/1984SE

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510(k)DeviceDecision
K850068Lune Au CurettesHCY · Traditional 04/08/1985SE
K844365Color Vision TestersHIT · Traditional 01/02/1985SE
K844362Ophthalmic ChairHMF · Traditional 12/11/1984SE
K844363Ophthalmic StandHMF · Traditional 12/05/1984SE

Questions and answers

When was Skiascopic Racks cleared by the FDA?

Skiascopic Racks (K844364) received a 510(k) decision of Substantially Equivalent on January 2, 1985, 50 days after the submission was received.

What is the product code of K844364?

The FDA product code is HMH – Rack, Skiascopic, a Class I (low risk) device regulated under 21 CFR 886.1750.