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FDA 510(k) Applications Submitted by Goldy Singh
FDA 510(k) Number
Submission Date
Device Name
Applicant
K090019
01/02/2009
NATUS NEUROWORKS, MODEL 104196
NATUS MEDICAL, INC.
K100126
01/19/2010
STELLATE GRIDVIEW
EXCEL-TECH LTD. (XLTEK)
K090277
02/04/2009
NATUS SLEEPWORKS, MODEL 104017
EXCEL-TECH LTD. (XLTEK)
K100683
03/10/2010
NEUROLINK IP MODEL: PK1117
NATUS MEDICAL INCORPORATED
K191200
05/06/2019
TULSA-PRO System
PROFOUND MEDICAL INC.
K211858
06/16/2021
TULSA-PRO System
Profound Medical Inc.
K081741
06/19/2008
NEUROLINK IP, MODEL PK1113
EXCEL-TECH LTD. (XLTEK)
K202286
08/12/2020
Tulsa-Pro System
Profound Medical Inc
K093304
10/21/2009
PROTEKTOR 32
NATUS MEDICAL, INC.
K083577
12/03/2008
HARMONIE SYSTEM
STELLATE SYSTEMS
K093949
12/23/2009
OLYMPIC BRAINZ MONITOR MODEL OBM70001
NATUS MEDICAL, INC.
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