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 B850

K-Number: K191323 · 2020-01-29

ApplicantGE Healthcare Finland Oy
Decision Date2020-01-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Carescape B850 is a medical device manufactured by GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2020-01-29 under approval number K191323. 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 B850?

Carescape B850 is a medical device that received FDA 510(k) clearance on 2020-01-29. It is manufactured by GE Healthcare Finland Oy. The 510(k) number is K191323.

When was Carescape B850 approved by the FDA?

Carescape B850 received FDA 510(k) clearance on 2020-01-29, under approval number K191323.

What company makes Carescape B850?

Carescape B850 is manufactured by GE Healthcare Finland Oy.

What is the FDA product code for Carescape B850?

The FDA product code for Carescape B850 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 K191249CARESCAPE B450 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

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.

↑