510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K191149Substantially Equivalent

Carescape B650

GE Healthcare Finland Oy, Helsinki, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191149 is the FDA 510(k) clearance record for CARESCAPE B650, a class II device, cleared for GE Healthcare Finland Oy on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 30 510(k) clearances for GE Healthcare Finland Oy, from to . As of , FDA records show 2 recalls naming K191149.

Clearance record

Decision date
Received
(266 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
GE Healthcare Finland Oy Kuortaneenkatu 2, Helsinki, FI
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