510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012915Substantially Equivalent

Dinamap Pro 1000 Monitor, Model 1000

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

K012915 is the FDA 510(k) clearance record for DINAMAP PRO 1000 MONITOR, MODEL 1000, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show one recall naming K012915.

Clearance record

Decision date
Received
(203 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 Medical Systems Information Technologies 4502 Woodland Corp.Blvd., Tampa FL
510(k) summary
Summary
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