510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K962930Unknown

Spacelabs Medical ECG Analysis System

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

K962930 is the FDA 510(k) clearance record for SPACELABS MEDICAL ECG ANALYSIS SYSTEM, a class II device, cleared for Spacelabs Medical, Inc. on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K962930.

Clearance record

Decision date
Received
(270 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
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 DQK

Trailing 12 months
27 clearances under product code DQK in the twelve months to November 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20262
November 20260