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FDA 510(k)

ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS

K-Number: K002985 · 2000-12-13

ApplicantIcs Medical Corp.
Decision Date2000-12-13
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS 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 2000-12-13 under 510(k) number K002985. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS?

ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS is a medical device that received FDA 510(k) clearance on 2000-12-13. The listed applicant is Ics Medical Corp.. The 510(k) number is K002985.

When did ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS receive FDA 510(k) clearance?

ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS received FDA 510(k) clearance on 2000-12-13, under 510(k) number K002985.

Who is the listed applicant for ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS?

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 EP AND CHARTR OAE SYSTEMS?

The FDA product code for ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS is GWJ.

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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.

K011181ICS MEDICAL CHARTR OAE WITH TYMPK991497ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEMK972631ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDERK960097CHARTR EPK931609CHARTR ENG SYSTEMK931608NCA-200

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Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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