510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K992749Substantially Equivalent

Ultraview Waveform Pager System, Model 91841

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

K992749 is the FDA 510(k) clearance record for ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841, a class II device, cleared for Spacelabs Medical, Inc. on under FDA product code MSX (System, Network And Communication, Physiological Monitors). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K992749.

Clearance record

Decision date
Received
(151 days to decision)
Product code
MSX System, Network And Communication, Physiological Monitors
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Spacelabs Medical, Inc. 15220 N. E. 40th St., Redmond WA
510(k) summary
Summary
Third party review
No

Clearances, product code MSX

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