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FDA 510(k)

CARESCAPE B450

K-Number: K191249 · 2020-01-24

ApplicantGE Healthcare Finland Oy
Decision Date2020-01-24
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARESCAPE B450 is a medical device manufactured by GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2020-01-24 under approval number K191249. 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 CARESCAPE B450?

CARESCAPE B450 is a medical device that received FDA 510(k) clearance on 2020-01-24. It is manufactured by GE Healthcare Finland Oy. The 510(k) number is K191249.

When was CARESCAPE B450 approved by the FDA?

CARESCAPE B450 received FDA 510(k) clearance on 2020-01-24, under approval number K191249.

What company makes CARESCAPE B450?

CARESCAPE B450 is manufactured by GE Healthcare Finland Oy.

What is the FDA product code for CARESCAPE B450?

The FDA product code for CARESCAPE B450 is MHX.

Other Devices by GE Healthcare Finland Oy

K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories K183394CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO K191323Carescape B850 K191322E-EEGX, N-EEGX K191149CARESCAPE B650 K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

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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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