FDA 510(k) Applications Submitted by Saket Bhatt

FDA 510(k) Number Submission Date Device Name Applicant
K210753 03/15/2021 KardiaMobile 6L AliveCor, Inc.
K150891 04/02/2015 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System Covidien LLC( Formerly Beacon Endoscopic Corp.)
K211370 05/04/2021 Tablo Hemodialysis System Outset Medical, Inc.
K191406 05/28/2019 KardiaMobile, KardiaStation AliveCor, Inc.
K211668 06/01/2021 KardiaMobile Card AliveCor, Inc.
K141894 07/14/2014 SHARKCORE FINE NEEDLE BIOPSY SYSTEM COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP)
K201985 07/17/2020 KardiaAI AliveCor, Inc.
K122161 07/20/2012 SJM CONFIRM ST. JUDE MEDICAL
K142198 08/11/2014 BNX Fine Needle Aspiration System Covidien LLC
K223248 10/21/2022 Tablo« Hemodialysis System Outset Medical, Inc.
K173559 11/17/2017 Barrx SB RFA Endoscopic Catheter Covidien llc


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