WALK400H

FDA 510(k) K091054 · Et Medical Devices Spa

Substantially Equivalent

510(k) numberK091054

Submission

Device name
WALK400H
Applicant
Et Medical Devices Spa
Cavareno(Tn), IT
Received
April 13, 2009
Decision date
July 27, 2009
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MWJ – Electrocardiograph, Ambulatory (Without Analysis)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2800
Specialty
Cardiovascular

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K233864ASSURE Wearable ECGMWJ · Traditional Kestra Medical Technologies, Inc.05/07/2024SE
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Questions and answers

When was WALK400H cleared by the FDA?

WALK400H (K091054) received a 510(k) decision of Substantially Equivalent on July 27, 2009, 105 days after the submission was received.

What is the product code of K091054?

The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.