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FDA 510(k)

CARESCAPE B450, E-musb

K-Number: K213363 · 2022-04-13

ApplicantGE Healthcare Finland Oy
Decision Date2022-04-13
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARESCAPE B450, E-musb is a medical device manufactured by GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2022-04-13 under approval number K213363. 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, E-musb?

CARESCAPE B450, E-musb is a medical device that received FDA 510(k) clearance on 2022-04-13. It is manufactured by GE Healthcare Finland Oy. The 510(k) number is K213363.

When was CARESCAPE B450, E-musb approved by the FDA?

CARESCAPE B450, E-musb received FDA 510(k) clearance on 2022-04-13, under approval number K213363.

What company makes CARESCAPE B450, E-musb?

CARESCAPE B450, E-musb is manufactured by GE Healthcare Finland Oy.

What is the FDA product code for CARESCAPE B450, E-musb?

The FDA product code for CARESCAPE B450, E-musb 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 K191249CARESCAPE B450 K191322E-EEGX, N-EEGX K191149CARESCAPE B650

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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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