AeviceMD

FDA 510(k) K243603 · Aevice Health Pte. , Ltd.

Substantially Equivalent

510(k) numberK243603

Submission

Device name
AeviceMD
Applicant
Aevice Health Pte. , Ltd.
Singapore, SG
Received
November 21, 2024
Decision date
May 5, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DSH – Recorder, Magnetic Tape, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2800
Specialty
Cardiovascular

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More from Edan Instruments, Inc.

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Questions and answers

When was AeviceMD cleared by the FDA?

AeviceMD (K243603) received a 510(k) decision of Substantially Equivalent on May 5, 2025, 165 days after the submission was received.

What is the product code of K243603?

The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.