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FDA 510(k)

LIFECARD CF COMPACT RECORDER

K-Number: K001025 · 2000-04-19

ApplicantReynolds Medical , Ltd.
Decision Date2000-04-19
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFECARD CF COMPACT 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 2000-04-19 under 510(k) number K001025. 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 LIFECARD CF COMPACT RECORDER?

LIFECARD CF COMPACT RECORDER is a medical device that received FDA 510(k) clearance on 2000-04-19. The listed applicant is Reynolds Medical , Ltd.. The 510(k) number is K001025.

When did LIFECARD CF COMPACT RECORDER receive FDA 510(k) clearance?

LIFECARD CF COMPACT RECORDER received FDA 510(k) clearance on 2000-04-19, under 510(k) number K001025.

Who is the listed applicant for LIFECARD CF COMPACT 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 LIFECARD CF COMPACT RECORDER?

The FDA product code for LIFECARD CF COMPACT 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 DAYK991211EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEMK972649CARDIOCALL CARDIAC EVENT RECORDER

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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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