Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CARESCAPE B650, E-musb

K-Number: K213181 · 2022-04-13

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

Device Summary

CARESCAPE B650, 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 K213181. 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, E-musb?

CARESCAPE B650, 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 K213181.

When was CARESCAPE B650, E-musb approved by the FDA?

CARESCAPE B650, E-musb received FDA 510(k) clearance on 2022-04-13, under approval number K213181.

What company makes CARESCAPE B650, E-musb?

CARESCAPE B650, E-musb is manufactured by GE Healthcare Finland Oy.

What is the FDA product code for CARESCAPE B650, E-musb?

The FDA product code for CARESCAPE B650, 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

View all 11 devices →

Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

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.

↑