510(k) K242931

Device
HFT750U
Applicant
Mekics Co., Ltd.
510(k) number
K242931
Product code
MNT
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-15
Date received
2024-09-25
Regulation
868.5895
Classification name
Sv70 Ventilator
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Sang-Hag Lee
Address
21, Sangjiseok-Gil, Paju-Si Gyeonggi-Do KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MNT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K122715STELLAR 150Resmed Germany, Inc.2013-06-17
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K113640STELLAR 150Resmed Germany, Inc.2012-04-05
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K103167STELLAR 150Resmed Germany, Inc.2011-03-01
K090113BREAS VIVO 40 SYSTEMBreas Medical AB2009-05-14
K082660V60 VENTILATOR, MODEL V8000Respironics California, Inc.2009-01-09
K071702BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40Breas Medical AB2008-02-15