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FDA 510(k)

AUTO DETECT FOR TELAHEART DR200/E-A

K-Number: K070014 · 2007-05-25

ApplicantNorth East Monitoring, Inc.
Decision Date2007-05-25
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUTO DETECT FOR TELAHEART DR200/E-A is the device name listed in this FDA 510(k) record. The listed applicant is North East Monitoring, Inc.. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K070014. 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 AUTO DETECT FOR TELAHEART DR200/E-A?

AUTO DETECT FOR TELAHEART DR200/E-A is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is North East Monitoring, Inc.. The 510(k) number is K070014.

When did AUTO DETECT FOR TELAHEART DR200/E-A receive FDA 510(k) clearance?

AUTO DETECT FOR TELAHEART DR200/E-A received FDA 510(k) clearance on 2007-05-25, under 510(k) number K070014.

Who is the listed applicant for AUTO DETECT FOR TELAHEART DR200/E-A?

The FDA 510(k) record lists North East Monitoring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO DETECT FOR TELAHEART DR200/E-A?

The FDA product code for AUTO DETECT FOR TELAHEART DR200/E-A is MWJ.

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Other records listing North East Monitoring, Inc. 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.

K081861HOLTER LX ANALYSISK061293TELAHEART DIGITAL RECORDERK041901SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDERK004007DR180+OXYK001288DR180-IIK983576DR180-R/OXY

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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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