510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203579Substantially Equivalent

Infinity Gateway Suite

Draeger Medical Systems, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203579 is the FDA 510(k) clearance record for Infinity Gateway Suite, a class II device, cleared for Draeger Medical Systems, Inc. on under FDA product code MSX (System, Network And Communication, Physiological Monitors). FDA records list 48 510(k) clearances for Draeger Medical Systems, Inc., from to . As of , FDA records show no recalls naming K203579.

Clearance record

Decision date
Received
(547 days to decision)
Product code
MSX System, Network And Communication, Physiological Monitors
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Draeger Medical Systems, Inc. 6 Tech Dr., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSX

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