Selector SL 01

FDA 510(k) K933220 · Futuremed Div. of Future Impex Corp.

Substantially Equivalent

510(k) numberK933220

Submission

Device name
Selector SL 01
Applicant
Futuremed Div. of Future Impex Corp.
Deerpark, NY, US
Received
July 1, 1993
Decision date
November 24, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EWO – Audiometer
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1050
Specialty
Ear, Nose, Throat

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Questions and answers

When was Selector SL 01 cleared by the FDA?

Selector SL 01 (K933220) received a 510(k) decision of Substantially Equivalent on November 24, 1993, 146 days after the submission was received.

What is the product code of K933220?

The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.