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FDA 510(k)

PROCARE MONITOR B20

K-Number: K122253 · 2013-03-22

ApplicantGe Medical Systems China Co., Ltd.
Decision Date2013-03-22
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROCARE MONITOR B20 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems China Co., Ltd.. It received FDA 510(k) clearance on 2013-03-22 under 510(k) number K122253. 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 PROCARE MONITOR B20?

PROCARE MONITOR B20 is a medical device that received FDA 510(k) clearance on 2013-03-22. The listed applicant is Ge Medical Systems China Co., Ltd.. The 510(k) number is K122253.

When did PROCARE MONITOR B20 receive FDA 510(k) clearance?

PROCARE MONITOR B20 received FDA 510(k) clearance on 2013-03-22, under 510(k) number K122253.

Who is the listed applicant for PROCARE MONITOR B20?

The FDA 510(k) record lists Ge Medical Systems China Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROCARE MONITOR B20?

The FDA product code for PROCARE MONITOR B20 is MHX.

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Other records listing Ge Medical Systems China Co., Ltd. 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.

K171580Monitor B125, Monitor B105K130584MONITOR B40K123238ACHILLESK120598PROCARE MONITOR B40K103633ACHILLESK102256GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND

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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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.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 Corporation

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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