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FDA 510(k)

MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS

K-Number: K102723 · 2010-12-09

ApplicantMemtec Corp.
Decision Date2010-12-09
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Memtec Corp.. It received FDA 510(k) clearance on 2010-12-09 under 510(k) number K102723. 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 MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS?

MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS is a medical device that received FDA 510(k) clearance on 2010-12-09. The listed applicant is Memtec Corp.. The 510(k) number is K102723.

When did MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS receive FDA 510(k) clearance?

MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS received FDA 510(k) clearance on 2010-12-09, under 510(k) number K102723.

Who is the listed applicant for MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS?

The FDA 510(k) record lists Memtec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS?

The FDA product code for MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS is MWJ.

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Other records listing Memtec Corp. 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.

K103427MOBILEECG SYSTEMK944180MODEL 700

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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