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FDA 510(k)

NORTHEAST MONITORING DR180

K-Number: K960925 · 1996-07-31

ApplicantNorth East Monitoring, Inc.
Decision Date1996-07-31
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NORTHEAST MONITORING DR180 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 1996-07-31 under 510(k) number K960925. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTHEAST MONITORING DR180?

NORTHEAST MONITORING DR180 is a medical device that received FDA 510(k) clearance on 1996-07-31. The listed applicant is North East Monitoring, Inc.. The 510(k) number is K960925.

When did NORTHEAST MONITORING DR180 receive FDA 510(k) clearance?

NORTHEAST MONITORING DR180 received FDA 510(k) clearance on 1996-07-31, under 510(k) number K960925.

Who is the listed applicant for NORTHEAST MONITORING DR180?

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 NORTHEAST MONITORING DR180?

The FDA product code for NORTHEAST MONITORING DR180 is DSH.

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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 RECORDERK041901SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDERK004007DR180+OXYK001288DR180-II

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Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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