510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091054Substantially Equivalent

Walk400h

Et Medical Devices SpA, Cavareno(Tn), IT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091054 is the FDA 510(k) clearance record for WALK400H, a class II device, cleared for Et Medical Devices Spa on under FDA product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)). FDA records list 3 510(k) clearances for Et Medical Devices Spa, from to . As of , FDA records show no recalls naming K091054.

Clearance record

Decision date
Received
(105 days to decision)
Product code
MWJ Electrocardiograph, Ambulatory (Without Analysis)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Et Medical Devices Spa 6, Via De Zinis, Cavareno(Tn), IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWJ

Trailing 12 months
5 clearances under product code MWJ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20261
September 20262
October 20260