A-Scan Roll-Around Stand

FDA 510(k) K900161 · Jedmed Instrument Co.

Substantially Equivalent

510(k) numberK900161

Submission

Device name
A-Scan Roll-Around Stand
Applicant
Jedmed Instrument Co.
St. Louis, MO, US
Received
January 12, 1990
Decision date
February 16, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HMG – Stand, Instrument, Ophthalmic, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.1860
Specialty
Ophthalmic

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K841759Ophthalmic TableHMG · Traditional Woodlyn, Inc.06/01/1984SE

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Questions and answers

When was A-Scan Roll-Around Stand cleared by the FDA?

A-Scan Roll-Around Stand (K900161) received a 510(k) decision of Substantially Equivalent on February 16, 1990, 35 days after the submission was received.

What is the product code of K900161?

The FDA product code is HMG – Stand, Instrument, Ophthalmic, Non-Powered, a Class I (low risk) device regulated under 21 CFR 886.1860.