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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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