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FDA 510(k)

CARESCAPE B650

K-Number: K191149 · 2020-01-21

ApplicantGE Healthcare Finland Oy
Decision Date2020-01-21
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARESCAPE B650 is a medical device manufactured by GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2020-01-21 under approval number K191149. 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 B650?

CARESCAPE B650 is a medical device that received FDA 510(k) clearance on 2020-01-21. It is manufactured by GE Healthcare Finland Oy. The 510(k) number is K191149.

When was CARESCAPE B650 approved by the FDA?

CARESCAPE B650 received FDA 510(k) clearance on 2020-01-21, under approval number K191149.

What company makes CARESCAPE B650?

CARESCAPE B650 is manufactured by GE Healthcare Finland Oy.

What is the FDA product code for CARESCAPE B650?

The FDA product code for CARESCAPE B650 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 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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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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