510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K181998Substantially Equivalent

CardioBand ECG Event Recorder

Samsung Strategy and Innovation Center (Ssic), San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181998 is the FDA 510(k) clearance record for CardioBand ECG Event Recorder, a class II device, cleared for Samsung Strategy and Innovation Center (Ssic) on under FDA product code DPS (Electrocardiograph). FDA records list one 510(k) clearance for Samsung Strategy and Innovation Center (Ssic). As of , FDA records show no recalls naming K181998.

Clearance record

Decision date
Received
(112 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Samsung Strategy and Innovation Center (Ssic) 3655 N. First St., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPS

Trailing 12 months
7 clearances under product code DPS in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20262
October 20261