510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K040969Substantially Equivalent

Poise Dataengine

Poise Technology Corporation, Hsin Chu City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040969 is the FDA 510(k) clearance record for POISE DATAENGINE, a class II device, cleared for Poise Technology Corporation on under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)). FDA records list one 510(k) clearance for Poise Technology Corporation. As of , FDA records show no recalls naming K040969.

Clearance record

Decision date
Received
(55 days to decision)
Product code
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Poise Technology Corporation 58 Fu-Chiun St., Hsin Chu City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWI

Trailing 12 months
5 clearances under product code MWI in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260