510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K897080Substantially Equivalent

Cardiocap(tm) CT-104 Monitor

Datex Division Instrumentarium Corp., Helsinki, Finland, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897080 is the FDA 510(k) clearance record for CARDIOCAP(TM) CT-104 MONITOR, a class II device, cleared for Datex Division Instrumentarium Corp. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 55 510(k) clearances for Datex Division Instrumentarium Corp., from to . As of , FDA records show no recalls naming K897080.

Clearance record

Decision date
Received
(75 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Datex Division Instrumentarium Corp. P.O. Box 446, Helsinki, Finland, FI
Third party review
No

Clearances, product code DRT

Trailing 12 months
4 clearances under product code DRT 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 DRT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260