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FDA 510(k)

SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER

K-Number: K041901 · 2004-08-31

ApplicantNorth East Monitoring, Inc.
Decision Date2004-08-31
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER 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 2004-08-31 under 510(k) number K041901. 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 SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER?

SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER is a medical device that received FDA 510(k) clearance on 2004-08-31. The listed applicant is North East Monitoring, Inc.. The 510(k) number is K041901.

When did SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER receive FDA 510(k) clearance?

SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER received FDA 510(k) clearance on 2004-08-31, under 510(k) number K041901.

Who is the listed applicant for SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER?

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 SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER?

The FDA product code for SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER 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 ANALYSISK070014AUTO DETECT FOR TELAHEART DR200/E-AK061293TELAHEART 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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