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FDA 510(k)

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

K-Number: K071984 · 2008-06-27

ApplicantCma Microdialysis AB
Decision Date2008-06-27
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cma Microdialysis AB. It received FDA 510(k) clearance on 2008-06-27 under 510(k) number K071984. 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 MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM?

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is Cma Microdialysis AB. The 510(k) number is K071984.

When did MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM received FDA 510(k) clearance on 2008-06-27, under 510(k) number K071984.

Who is the listed applicant for MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM?

The FDA 510(k) record lists Cma Microdialysis AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM?

The FDA product code for MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM is GWM.

Related Clinical Trials

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.

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Other records listing Cma Microdialysis AB 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.

K102077MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEMK060554CMA CEREBRAL TISSUE MONITORING SYSTEMK020285CMA CEREBRAL TISSUE MONITORING SYSTEM

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

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