510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974903Substantially Equivalent

Gas Module II, Model 0998-00-0143

Datascope Corp., Paramus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974903 is the FDA 510(k) clearance record for GAS MODULE II, MODEL 0998-00-0143, a class II device, cleared for Datascope Corp. on under FDA product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)). FDA records list 139 510(k) clearances for Datascope Corp., from to . As of , FDA records show no recalls naming K974903.

Clearance record

Decision date
Received
(72 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
Datascope Corp. 580 Winters Ave., Paramus NJ
510(k) summary
Statement
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