510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864900Substantially Equivalent

Viggo Exacta Pressure Monitoring Kit

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

K864900 is the FDA 510(k) clearance record for VIGGO EXACTA PRESSURE MONITORING KIT, a class II device, cleared for Ohmeda Medical on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K864900.

Clearance record

Decision date
Received
(107 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Ohmeda Medical 2007 Pan Am Cir., Tampa FL
Third party review
No

Clearances, product code FMG

Trailing 12 months

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

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