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FDA 510(k)

TRACKER-2 CHANNEL ECG TAPE RECORDER

K-Number: K821516 · 1982-05-28

ApplicantReynolds Medical , Ltd.
Decision Date1982-05-28
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRACKER-2 CHANNEL ECG TAPE RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Reynolds Medical , Ltd.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821516. 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 TRACKER-2 CHANNEL ECG TAPE RECORDER?

TRACKER-2 CHANNEL ECG TAPE RECORDER is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Reynolds Medical , Ltd.. The 510(k) number is K821516.

When did TRACKER-2 CHANNEL ECG TAPE RECORDER receive FDA 510(k) clearance?

TRACKER-2 CHANNEL ECG TAPE RECORDER received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821516.

Who is the listed applicant for TRACKER-2 CHANNEL ECG TAPE RECORDER?

The FDA 510(k) record lists Reynolds Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACKER-2 CHANNEL ECG TAPE RECORDER?

The FDA product code for TRACKER-2 CHANNEL ECG TAPE RECORDER is DSH.

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Other records listing Reynolds Medical , Ltd. 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.

K024283CARDIODIRECT, MODELS 12M, 12I, 12SK013367CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPHK011345CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEMK011837LIFECARD CF 7 DAYK001025LIFECARD CF COMPACT RECORDERK991211EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM

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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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