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FDA 510(k)

LifeLens Wireless ECG Monitor

K-Number: K203168 · 2021-07-20

ApplicantLifeLens Technologies, Inc.
Decision Date2021-07-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeLens Wireless ECG Monitor is the device name listed in this FDA 510(k) record. The listed applicant is LifeLens Technologies, Inc.. It received FDA 510(k) clearance on 2021-07-20 under 510(k) number K203168. 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 LifeLens Wireless ECG Monitor?

LifeLens Wireless ECG Monitor is a medical device that received FDA 510(k) clearance on 2021-07-20. The listed applicant is LifeLens Technologies, Inc.. The 510(k) number is K203168.

When did LifeLens Wireless ECG Monitor receive FDA 510(k) clearance?

LifeLens Wireless ECG Monitor received FDA 510(k) clearance on 2021-07-20, under 510(k) number K203168.

Who is the listed applicant for LifeLens Wireless ECG Monitor?

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

What is the FDA product code for LifeLens Wireless ECG Monitor?

The FDA product code for LifeLens Wireless ECG Monitor 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.

NCT07676227Pulse Oximetry Performance Test for PaMo - Controlled Desaturation TestCOMPLETED

Other records listing LifeLens Technologies, Inc. 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.

K260157LifeLens Physiological Monitor

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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