510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902493Substantially Equivalent

Cardiocap II Cg-2Gs, 2G, 1Gs, 1G, 2Cg, Cs Monitor

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

K902493 is the FDA 510(k) clearance record for CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR, a class I device, cleared for Datex Division Instrumentarium Corp. on under FDA product code DRI (Monitor, Line Isolation). FDA records list 55 510(k) clearances for Datex Division Instrumentarium Corp., from to . As of , FDA records show no recalls naming K902493.

Clearance record

Decision date
Received
(31 days to decision)
Product code
DRI Monitor, Line Isolation
Regulation
21 CFR 870.2620
Device class
Class I
Review panel
Cardiovascular
Applicant
Datex Division Instrumentarium Corp. P.O. Box 446, Helsinki, Finland, FI
Third party review
No

Clearances, product code DRI

Trailing 12 months

FDA records hold no clearances under product code DRI in the trailing twelve months.

FDA records show no clearances under product code DRI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260