510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K942058Substantially Equivalent

Spacelabs Medical ECG Module (Model 90492)

GE Healthcare, Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942058 is the FDA 510(k) clearance record for SPACELABS MEDICAL ECG MODULE (MODEL 90492), a class II device, cleared for Spacelabs Medical, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K942058.

Clearance record

Decision date
Received
(383 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Spacelabs Medical, Inc. P.O. Box 97013, Redmond WA
510(k) summary
Summary
Third party review
No

Clearances, product code DSI

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