FDA 510(k)

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

K-Number: K102077 · 2011-01-14

Decision Date2011-01-14

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 2011-01-14 under 510(k) number K102077. 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 2011-01-14. The listed applicant is Cma Microdialysis AB. The 510(k) number is K102077.

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 2011-01-14, under 510(k) number K102077.

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.

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Other records listing Cma Microdialysis AB as applicant

K071984MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM K060554CMA CEREBRAL TISSUE MONITORING SYSTEM K020285CMA CEREBRAL TISSUE MONITORING SYSTEM

Related Devices (Code: GWM)

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Official Source

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