510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K883254Substantially Equivalent

Multinex Monitor (Modification)

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

K883254 is the FDA 510(k) clearance record for MULTINEX MONITOR (MODIFICATION), a class II device, cleared for Datascope Corp. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 139 510(k) clearances for Datascope Corp., from to . As of , FDA records show no recalls naming K883254.

Clearance record

Decision date
Received
(41 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Datascope Corp. Winters Ave., Paramus NJ
Third party review
No

Clearances, product code CCL

Trailing 12 months
1 clearance under product code CCL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260