510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082045Substantially Equivalent

Modification to Mcare 300 Vital Signs Monitor, Model 91220

GE Healthcare, Las Vegas NV / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082045 is the FDA 510(k) clearance record for MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220, a class II device, cleared for Spacelabs Medical, Inc. on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show one recall naming K082045.

Clearance record

Decision date
Received
(14 days to decision)
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Spacelabs Medical, Inc. 2235 E. Flamingo Rd., Suite 201g, Las Vegas NV
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MHX

Trailing 12 months
15 clearances under product code MHX in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MHX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20261
March 20260
April 20263
May 20262
June 20261
July 20261
August 20263
September 20261
October 20260