510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880572Substantially Equivalent

Ohmeda 2350 Finapres(r) Blood Pressure Monitor

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

K880572 is the FDA 510(k) clearance record for OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR, a class II device, cleared for Ohmeda Medical on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K880572.

Clearance record

Decision date
Received
(89 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Ohmeda Medical 355 Inverness Dr.South, Englewood CO
Third party review
No

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261