Coronet 100

FDA 510(k) K913785 · Micro-Shev , Ltd.

Substantially Equivalent

510(k) numberK913785

Submission

Device name
Coronet 100
Applicant
Micro-Shev , Ltd.
Efrat, IL
Received
August 23, 1991
Decision date
December 31, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GWJ – Stimulator, Auditory, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1900
Specialty
Neurology

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More from Gn Otometrics

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K900378Emg Option for Microshev 4000JXE · Traditional 04/10/1990SE
K894608Model 4000 Evoked Potential Measurement SystemGWF · Traditional 12/29/1989SE
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Questions and answers

When was Coronet 100 cleared by the FDA?

Coronet 100 (K913785) received a 510(k) decision of Substantially Equivalent on December 31, 1991, 130 days after the submission was received.

What is the product code of K913785?

The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.