Throat-A-Scope

FDA 510(k) K923227 · Truphatek, Ltd.

Substantially Equivalent

510(k) numberK923227

Submission

Device name
Throat-A-Scope
Applicant
Truphatek, Ltd.
Netanya, IL
Received
July 1, 1992
Decision date
December 4, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EQH – Source, Carrier, Fiberoptic Light
Device class
Class I (low risk)
Regulation
21 CFR 874.4350
Specialty
Ear, Nose, Throat

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K932771Battery Powered, Disposable Endoscope Light SourceEQH · Traditional Xomed-Treace, Inc.08/24/1994SE
K941661GM Opti*Cam Camer with Dental Fiber Optic LightEQH · Traditional Gm Engineering, Inc.08/23/1994SE
K941662GM Opti*Cam Camera with ENT Fiber Optic LightEQH · Traditional Gm Engineering, Inc.07/20/1994SE
K934911Saphire Plus Surgical MirrorEQH · Traditional San Diego Swiss Machining, Inc.06/21/1994SE
K932131Mid Labs Twin IlluminatorEQH · Traditional Medical Instrument Development Laboratories, Inc.04/01/1994SE
K930123Aspirating Endo Ocular ProbeEQH · Traditional Surgical Technologies, Inc.02/16/1994SE
K933145Fiberoptic Lightsources and CarriersEQH · Traditional Electro Fiberoptics Corp.09/07/1993SE

More from Electro Fiberoptics Corp.

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K920272OrielHLJ · Traditional 07/09/1992SE
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Questions and answers

When was Throat-A-Scope cleared by the FDA?

Throat-A-Scope (K923227) received a 510(k) decision of Substantially Equivalent on December 4, 1992, 156 days after the submission was received.

What is the product code of K923227?

The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.