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FDA 510(k)

SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM

K-Number: K050731 · 2005-05-19

ApplicantGe Medical Systems Information Technologies
Decision Date2005-05-19
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 2005-05-19 under 510(k) number K050731. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM?

SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-19. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K050731.

When did SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM receive FDA 510(k) clearance?

SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM received FDA 510(k) clearance on 2005-05-19, under 510(k) number K050731.

Who is the listed applicant for SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM?

The FDA product code for SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM is MWJ.

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Other records listing Ge Medical Systems Information Technologies as applicant

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Related Devices (Code: MWJ)

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.

K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)Shenzhen Xinyan Medical Technology Co.,ltd.K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, Inc.

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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