510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K032882Substantially Equivalent

Recom Battery-Operated Ambulatory Digital Wireless ECG Monitor, Model 100

Recom Managed Systems, Inc., Valley Village CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032882 is the FDA 510(k) clearance record for RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100, a class II device, cleared for Recom Managed Systems, Inc. on under FDA product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)). FDA records list one 510(k) clearance for Recom Managed Systems, Inc. As of , FDA records show no recalls naming K032882.

Clearance record

Decision date
Received
(135 days to decision)
Product code
MWJ Electrocardiograph, Ambulatory (Without Analysis)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Recom Managed Systems, Inc. 4705 Laurel Canyon Blvd., Valley Village CA
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