Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DR180+OXY

K-Number: K004007 · 2001-01-25

ApplicantNorth East Monitoring, Inc.
Decision Date2001-01-25
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DR180+OXY 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 2001-01-25 under 510(k) number K004007. 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 DR180+OXY?

DR180+OXY is a medical device that received FDA 510(k) clearance on 2001-01-25. The listed applicant is North East Monitoring, Inc.. The 510(k) number is K004007.

When did DR180+OXY receive FDA 510(k) clearance?

DR180+OXY received FDA 510(k) clearance on 2001-01-25, under 510(k) number K004007.

Who is the listed applicant for DR180+OXY?

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 DR180+OXY?

The FDA product code for DR180+OXY is DSH.

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 RECORDERK001288DR180-IIK983576DR180-R/OXY

View all 9 devices →

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.

↑