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FDA 510(k)

HOLTER PERFORMER

K-Number: K813602 · 1982-01-29

ApplicantApplied Cardiac Systems
Decision Date1982-01-29
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER PERFORMER is the device name listed in this FDA 510(k) record. The listed applicant is Applied Cardiac Systems. It received FDA 510(k) clearance on 1982-01-29 under 510(k) number K813602. 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 HOLTER PERFORMER?

HOLTER PERFORMER is a medical device that received FDA 510(k) clearance on 1982-01-29. The listed applicant is Applied Cardiac Systems. The 510(k) number is K813602.

When did HOLTER PERFORMER receive FDA 510(k) clearance?

HOLTER PERFORMER received FDA 510(k) clearance on 1982-01-29, under 510(k) number K813602.

Who is the listed applicant for HOLTER PERFORMER?

The FDA 510(k) record lists Applied Cardiac Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLTER PERFORMER?

The FDA product code for HOLTER PERFORMER 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 Applied Cardiac Systems 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.

K042413ACS MODEL NCP-2K860249THE HOLTER REPORTER (TM)K833823HOLTER PERFORMER FEATHER WEIGHT/CASS

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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