FDA 510(k) Applications Submitted by David Ni

FDA 510(k) Number	Submission Date	Device Name	Applicant
K230173	01/20/2023	Servo-air Lite Ventilator System	Maquet Critical Care AB
K201874	07/07/2020	Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1	Maquet Critical Care AB
K192604	09/20/2019	Servo-air 4.0 Ventilator System	Maquet Critica Care AB
K123565	11/20/2012	PRESTO 1000 SYSTEM	PHYSIOSONICS, INC
K974096	10/30/1997	CRX DIAMOND VALVE	PHOENIX BIOMEDICAL CORP.
K980869	03/06/1998	SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143	BIOTRONIK, INC.
K982272	06/29/1998	GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018	BIOTRONIK, INC.
K072499	09/05/2007	NOVOFLO CATHETER LT	NOVOSCI, INC.
K063355	11/07/2006	D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW	NOVOSCI CORP.
K210785	03/16/2021	Disposable Surgical Gowns	Chongqing Litai Fashion Group Limited Company
K062795	09/18/2006	MUGARD MUCOADHESIVE ORAL WOUND RINSE	ACCESS PHARMACEUTICALS, INC
K970040	01/06/1997	SPINE-TECH BONE HARVESTER	SPINE-TECH, INC.
K980288	01/26/1998	SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM	SPINE-TECH, INC.
K190814	03/29/2019	AccuFill Bone Substitute Material	Zimmer Knee Creations
K960169	01/16/1996	CARBOMEDICS VALVE TESTER	CARBOMEDICS, INC.
K960923	03/06/1996	CARBOMEDICS MITRAL ROTATOR	CARBOMEDICS, INC.
K030453	02/11/2003	COOLTOUCH ND: YAG LASER SYSTEM	NEW STAR LASERS, INC.
K962791	07/17/1996	NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM	NEW STAR LASERS, INC.