510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905754Substantially Equivalent

Capnomac Ultima Anesthesia Monitor

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

K905754 is the FDA 510(k) clearance record for CAPNOMAC ULTIMA ANESTHESIA MONITOR, a class II device, cleared for Datex Division Instrumentarium Corp. on under FDA product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)). FDA records list 55 510(k) clearances for Datex Division Instrumentarium Corp., from to . As of , FDA records show no recalls naming K905754.

Clearance record

Decision date
Received
(175 days to decision)
Product code
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Regulation
21 CFR 868.1620
Device class
Class II
Review panel
Anesthesiology
Applicant
Datex Division Instrumentarium Corp. P.O. Box 446, Helsinki, Finland, FI
Third party review
No

Clearances, product code CBS

Trailing 12 months

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

FDA records show no clearances under product code CBS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBS, 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