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FDA 510(k)

WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM

K-Number: K913600 · 1991-10-16

ApplicantRalin Laboratories, Inc.
Decision Date1991-10-16
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ralin Laboratories, Inc.. It received FDA 510(k) clearance on 1991-10-16 under 510(k) number K913600. 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 WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM?

WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-16. The listed applicant is Ralin Laboratories, Inc.. The 510(k) number is K913600.

When did WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM receive FDA 510(k) clearance?

WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM received FDA 510(k) clearance on 1991-10-16, under 510(k) number K913600.

Who is the listed applicant for WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM?

The FDA 510(k) record lists Ralin Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM?

The FDA product code for WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM is DSH.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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