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FDA 510(k)

ECG MEDATAPE-601

K-Number: K812763 · 1981-10-20

ApplicantHospital Equipment Service
Decision Date1981-10-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG MEDATAPE-601 is the device name listed in this FDA 510(k) record. The listed applicant is Hospital Equipment Service. It received FDA 510(k) clearance on 1981-10-20 under 510(k) number K812763. 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 ECG MEDATAPE-601?

ECG MEDATAPE-601 is a medical device that received FDA 510(k) clearance on 1981-10-20. The listed applicant is Hospital Equipment Service. The 510(k) number is K812763.

When did ECG MEDATAPE-601 receive FDA 510(k) clearance?

ECG MEDATAPE-601 received FDA 510(k) clearance on 1981-10-20, under 510(k) number K812763.

Who is the listed applicant for ECG MEDATAPE-601?

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

What is the FDA product code for ECG MEDATAPE-601?

The FDA product code for ECG MEDATAPE-601 is DSH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hospital Equipment Service 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.

K812793P.E.T.

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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