510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K884539Substantially Equivalent

Holter 24-Hour ECG Playback, Model 150

Rmv Medical (Romavat, Inc.), Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884539 is the FDA 510(k) clearance record for HOLTER 24-HOUR ECG PLAYBACK, MODEL 150, a class II device, cleared for Rmv Medical (Romavat, Inc.) on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list one 510(k) clearance for Rmv Medical (Romavat, Inc.). As of , FDA records show no recalls naming K884539.

Clearance record

Decision date
Received
(81 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Rmv Medical (Romavat, Inc.) 250 Golden Cir. Dr., #202, Santa Ana CA
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260