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FDA 510(k)

ICS MEDICAL CHARTR OAE WITH TYMP

K-Number: K011181 · 2001-06-25

ApplicantIcs Medical Corp.
Decision Date2001-06-25
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ICS MEDICAL CHARTR OAE WITH TYMP is the device name listed in this FDA 510(k) record. The listed applicant is Ics Medical Corp.. It received FDA 510(k) clearance on 2001-06-25 under 510(k) number K011181. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICS MEDICAL CHARTR OAE WITH TYMP?

ICS MEDICAL CHARTR OAE WITH TYMP is a medical device that received FDA 510(k) clearance on 2001-06-25. The listed applicant is Ics Medical Corp.. The 510(k) number is K011181.

When did ICS MEDICAL CHARTR OAE WITH TYMP receive FDA 510(k) clearance?

ICS MEDICAL CHARTR OAE WITH TYMP received FDA 510(k) clearance on 2001-06-25, under 510(k) number K011181.

Who is the listed applicant for ICS MEDICAL CHARTR OAE WITH TYMP?

The FDA 510(k) record lists Ics Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICS MEDICAL CHARTR OAE WITH TYMP?

The FDA product code for ICS MEDICAL CHARTR OAE WITH TYMP is EWO.

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Other records listing Ics Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K002985ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMSK991497ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEMK972631ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDERK960097CHARTR EPK931609CHARTR ENG SYSTEMK931608NCA-200

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Related Devices (Code: EWO)

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K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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