510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953175Substantially Equivalent

As/3 Estpr Module

Datex Division Instrumentarium Corp., Tewksbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953175 is the FDA 510(k) clearance record for AS/3 ESTPR MODULE, a class II device, cleared for Datex Division Instrumentarium Corp. on under FDA product code MLD (Monitor, St Segment With Alarm). FDA records list 55 510(k) clearances for Datex Division Instrumentarium Corp., from to . As of , FDA records show no recalls naming K953175.

Clearance record

Decision date
Received
(580 days to decision)
Product code
MLD Monitor, St Segment With Alarm
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Datex Division Instrumentarium Corp. 2 Highwood Dr., Tewksbury MA
510(k) summary
Summary
Third party review
No

Clearances, product code MLD

Trailing 12 months

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

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