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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sv70 Ventilator
510(k) Number K242931
Device Name HFT750U
Applicant
Mekics Co., Ltd.
21, Sangjiseok-Gil, Paju-Si
Gyeonggi-Do,  KR
Applicant Contact Sang-Hag Lee
Correspondent
ProMedic Consulting, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5895
Classification Product Code
MNT  
Date Received09/25/2024
Decision Date 05/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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