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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 the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2020-01-21 under 510(k) 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. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K191149.

When did CARESCAPE B650 receive FDA 510(k) clearance?

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

Who is the listed applicant for CARESCAPE B650?

The FDA 510(k) record lists GE Healthcare Finland Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARESCAPE B650?

The FDA product code for CARESCAPE B650 is MHX.

Other records listing GE Healthcare Finland Oy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)K213363CARESCAPE B450, E-musbK213336Carescape B850, E-musbK213181CARESCAPE B650, E-musbK211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessoriesK191323Carescape B850

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Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo CorporationK252840M12 Telemetry SystemGlobal Instrumentation, LLCK260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.

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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