510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905369Substantially Equivalent

Ust-2266U-5 Cw Doppler Transducer

GE Medical Systems Information Technologies, Inc., Wallingford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905369 is the FDA 510(k) clearance record for UST-2266U-5 CW DOPPLER TRANSDUCER, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code JOP (Transducer, Ultrasonic). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K905369.

Clearance record

Decision date
Received
(74 days to decision)
Product code
JOP Transducer, Ultrasonic
Regulation
21 CFR 870.2880
Device class
Class II
Review panel
Cardiovascular
Applicant
Ge Medical Systems Information Technologies 61 Barnes Park Rd. N., Wallingford CT
Third party review
No

Clearances, product code JOP

Trailing 12 months

FDA records hold no clearances under product code JOP in the trailing twelve months.

FDA records show no clearances under product code JOP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260