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FDA 510(k)

CHARTR ENG SYSTEM

K-Number: K931609 · 1995-09-26

ApplicantIcs Medical Corp.
Decision Date1995-09-26
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CHARTR ENG SYSTEM 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 1995-09-26 under 510(k) number K931609. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHARTR ENG SYSTEM?

CHARTR ENG SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-26. The listed applicant is Ics Medical Corp.. The 510(k) number is K931609.

When did CHARTR ENG SYSTEM receive FDA 510(k) clearance?

CHARTR ENG SYSTEM received FDA 510(k) clearance on 1995-09-26, under 510(k) number K931609.

Who is the listed applicant for CHARTR ENG SYSTEM?

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 CHARTR ENG SYSTEM?

The FDA product code for CHARTR ENG SYSTEM is GWM.

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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 TYMPK002985ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMSK991497ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEMK972631ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDERK960097CHARTR EPK931608NCA-200

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Related Devices (Code: GWM)

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.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGK240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

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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