510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K863535Substantially Equivalent

Life-Trace 18 Single-Trace Cardiac Monitor/record.

Elekta Limited, Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863535 is the FDA 510(k) clearance record for LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD., a class II device, cleared for Computerized Medical Systems, Inc. on under FDA product code DPS (Electrocardiograph). FDA records list 58 510(k) clearances for ELEKTA LIMITED, from to . As of , FDA records show no recalls naming K863535.

Clearance record

Decision date
Received
(117 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Computerized Medical Systems, Inc. 3555 Woodhead Dr., Northbrook IL
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