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FDA 510(k)

AeviceMD

K-Number: K223382 · 2023-07-07

ApplicantAevice Health Pte. , Ltd.
Decision Date2023-07-07
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AeviceMD is the device name listed in this FDA 510(k) record. The listed applicant is Aevice Health Pte. , Ltd.. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K223382. 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 AeviceMD?

AeviceMD is a medical device that received FDA 510(k) clearance on 2023-07-07. The listed applicant is Aevice Health Pte. , Ltd.. The 510(k) number is K223382.

When did AeviceMD receive FDA 510(k) clearance?

AeviceMD received FDA 510(k) clearance on 2023-07-07, under 510(k) number K223382.

Who is the listed applicant for AeviceMD?

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

What is the FDA product code for AeviceMD?

The FDA product code for AeviceMD is DSH.

Other records listing Aevice Health Pte. , 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.

K243603AeviceMD

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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