510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942685Substantially Equivalent

ECG Review Station

Mortara Instrument, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942685 is the FDA 510(k) clearance record for ECG REVIEW STATION, a class II device, cleared for Mortara Instrument, Inc. on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 51 510(k) clearances for Mortara Instrument, Inc., from to . As of , FDA records show no recalls naming K942685.

Clearance record

Decision date
Received
(1,162 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
Device class
Class II
Review panel
Cardiovascular
Applicant
Mortara Instrument, Inc. 7865 N. 86th St., Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code DXJ

Trailing 12 months

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

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