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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K243268
Device Name TipTraQ (TTQ001)
Applicant
Pranaq Pte. , Ltd.
331 N. Bridge Rd.
#12-03, Odeon Towers
Singapore,  SG 188720
Applicant Contact Jerry Chen
Correspondent
Medignite Consulting, LLC
1709 Saracen Rd.
Austin,  TX  78733
Correspondent Contact Amy Herder
Regulation Number868.2375
Classification Product Code
MNR  
Date Received10/15/2024
Decision Date 02/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT06351878
NCT06634693
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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