510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203088Substantially Equivalent

Infinity Acute Care System (IACS) Monitoring System

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

K203088 is the FDA 510(k) clearance record for Infinity Acute Care System (IACS) Monitoring System, a class II device, cleared for Draeger Medical Systems, Inc. on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 48 510(k) clearances for Draeger Medical Systems, Inc., from to . As of , FDA records show one recall naming K203088.

Clearance record

Decision date
Received
(476 days to decision)
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.1025
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 MHX

Trailing 12 months
15 clearances under product code MHX in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MHX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20261
March 20260
April 20263
May 20262
June 20261
July 20261
August 20263
September 20261
October 20260