510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993826Substantially Equivalent

Narkomed 6000

Draeger, Inc., Telford PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993826 is the FDA 510(k) clearance record for NARKOMED 6000, a class II device, cleared for Draeger Medical, Inc. on under FDA product code MLC (Monitor, St Segment). FDA records list 84 510(k) clearances for DRAEGER, INC., from to . As of , FDA records show no recalls naming K993826.

Clearance record

Decision date
Received
(132 days to decision)
Product code
MLC Monitor, St Segment
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Draeger Medical, Inc. 3135 Quarry Rd., Telford PA
510(k) summary
Summary
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