FDA 510(k) Applications Submitted by Peter Yixin Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140131 |
01/17/2014 |
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET |
EMED TECHNOLOGIES CORPORATION |
| K140133 |
01/17/2014 |
INFUSET FLOW CONTROL EXTENSION SET |
EMED TECHNOLOGIES CORPORATION |
| K161906 |
07/12/2016 |
SCIg60 Infuser |
EMED TECHNOLOGIES CORPORATION |
| K142319 |
08/20/2014 |
SCIg60 Infuser, Infuset |
EMED TECHNOLOGIES CORPORATION |
| K213429 |
10/21/2021 |
AccuSert Needle Inserter |
Emed Technologies Corporation |
| K123729 |
12/05/2012 |
VERSARATE FLOW RATE CONTROLER |
EMED TECHNOLOGIES CORPORATION |
| K173783 |
12/13/2017 |
SCIg60 Infusion System |
EMED Technologies Corporation |
| K955160 |
11/13/1995 |
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER |
EVERAPEX DESIGN & MARKETING CORP. |
| K961034 |
03/11/1996 |
SUNGLASSES |
KYLIE ENTERPRISE CO. LTD. |
| K050098 |
01/18/2005 |
DDAT OMT |
DDAT(UK) LTD |
| K090721 |
03/18/2009 |
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 |
Medtronic |
| K122777 |
09/11/2012 |
NBX - NON BRIDGING EXTERNAL FIXATOR HAND |
NUTEK ORTHOPAEDICS, INC. |
| K082833 |
09/26/2008 |
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER |
NUTEK ORTHOPAEDICS, INC. |
| K080123 |
01/17/2008 |
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 |
WAKO CHEMICALS USA, INC. |
| K080125 |
01/17/2008 |
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 |
WAKO CHEMICALS USA, INC. |
| K093624 |
11/23/2009 |
OPTISCAN MODEL OPTISCAN CEIS |
OPTISCAN PTY LTD. |
| K110287 |
01/31/2011 |
PHILIPS ECG LEADWIRE SET |
PHILIPS MEDICAL SYSTEMS |
| K120815 |
03/19/2012 |
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE |
PHILIPS MEDICAL SYSTEMS |
| K071885 |
07/09/2007 |
ANTIMICROBIAL AND SINGLE-PATIENT CUFFS |
PHILIPS MEDICAL SYSTEMS |
| K060816 |
03/27/2006 |
MIM 4.0 (NEURO |
MIMVISTA CORP. |
| K071964 |
07/16/2007 |
MIM 4.1 (SEASTAR) |
MIMVISTA CORP. |
| K062163 |
07/28/2006 |
MIMVIEWER |
MIMVISTA CORP. |
| K052379 |
08/30/2005 |
MIM 3.5 (CIRCA) |
MIMVISTA CORP. |
| K030039 |
01/06/2003 |
PATHWAY STM-10 PELVIC FLOOR STIMULATOR |
THE PROMETHEUS GROUP |
| K180225 |
01/26/2018 |
GSI Viewer with GSI Fat Option |
GE Medical Systems SCS |
| K211180 |
04/20/2021 |
Liver Suite |
GE Medical Systems SCS |
| K152584 |
09/10/2015 |
Stroke VCAR |
GE MEDICAL SYSTEMS SCS |
| K183210 |
11/19/2018 |
Thoracic VCAR with GSI Pulmonary Perfusion |
GE Medical Systems SCS |
| K960761 |
02/26/1996 |
PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 |
THE PROMETHEUS GROUP |
| K973537 |
09/18/1997 |
PATHWAY ELECTROMYOGRAPH |
THE PROMETHEUS GROUP |
| K141493 |
06/05/2014 |
PROXIMAL HUMERUS PLATING SYSTEM |
Miami Device Solutions |
| K212105 |
07/06/2021 |
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF |
PZMedical Technology Co., Ltd. |
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