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FDA 510(k)

CAPNOSTAT / CAPNOFLEX CO2 SYSTEM

K-Number: K083750 · 2009-03-23

ApplicantGe Medical Systems Information Technologies
Decision Date2009-03-23
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPNOSTAT / CAPNOFLEX CO2 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K083750. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPNOSTAT / CAPNOFLEX CO2 SYSTEM?

CAPNOSTAT / CAPNOFLEX CO2 SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K083750.

When did CAPNOSTAT / CAPNOFLEX CO2 SYSTEM receive FDA 510(k) clearance?

CAPNOSTAT / CAPNOFLEX CO2 SYSTEM received FDA 510(k) clearance on 2009-03-23, under 510(k) number K083750.

Who is the listed applicant for CAPNOSTAT / CAPNOFLEX CO2 SYSTEM?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPNOSTAT / CAPNOFLEX CO2 SYSTEM?

The FDA product code for CAPNOSTAT / CAPNOFLEX CO2 SYSTEM is MHX.

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Other records listing Ge Medical Systems Information Technologies as applicant

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Related Devices (Code: MHX)

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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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