510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926099Substantially Equivalent

Datascope 6000 Monitor

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

K926099 is the FDA 510(k) clearance record for DATASCOPE 6000 MONITOR, a class II device, cleared for Datascope Corp. on under FDA product code MLC (Monitor, St Segment). FDA records list 139 510(k) clearances for Datascope Corp., from to . As of , FDA records show no recalls naming K926099.

Clearance record

Decision date
Received
(246 days to decision)
Product code
MLC Monitor, St Segment
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Datascope Corp. 580 Winters Ave., Paramus NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MLC

Trailing 12 months

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

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