FDA 510(k) Applications Submitted by James Ren
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K161390 |
05/19/2016 |
Vinyl Exam Gloves, Powder Free, Clear |
Zibo Hongchin Plastic and Rubber Co., Ltd |
| K041487 |
06/04/2004 |
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT |
USA INSTRUMENTS, INC. |
| K041695 |
06/22/2004 |
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE |
USA INSTRUMENTS, INC. |
| K042009 |
07/26/2004 |
MARK III PHASED ARRAY SHOULDER COIL |
USA INSTRUMENTS, INC. |
| K042186 |
08/12/2004 |
3.0T 8-CHANNEL CTL SPINE ARRAY |
USA INSTRUMENTS, INC. |
| K042207 |
08/16/2004 |
11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL |
USA INSTRUMENTS, INC. |
| K042342 |
08/30/2004 |
MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL |
USA INSTRUMENTS, INC. |
| K010093 |
01/11/2001 |
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 |
DRAGER MEDIZINTECHNIK GMBH |
| K980208 |
01/20/1998 |
DIVAN ANESTHESIA VENTILATOR |
DRAEGER MEDICAL, INC. |
| K980553 |
02/12/1998 |
NARKOMED 6000 MODEL NUMBER NM6000 |
DRAEGER MEDICAL, INC. |
| K980886 |
03/09/1998 |
BABYTHERM 8000 LDR |
DRAEGER MEDICAL, INC. |
| K040642 |
03/11/2004 |
LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA |
DRAEGET MEDICAL AG & CO. KGAA |
| K010724 |
03/12/2001 |
SOLA 700,SOLA 500, SOLA 300 |
DRAGER MEDIZINTECHNIK GMBH |
| K010793 |
03/16/2001 |
OXYLOG 1000, MODEL 2M86840 |
DRAGER MEDIZINTECHNIK GMBH |
| K971923 |
05/23/1997 |
DRAGER-VAPOR 2000 |
DRAEGER MEDICAL, INC. |
| K953228 |
07/10/1995 |
NARKOMED AV2+ ANESTHESIA VENTILATOR |
DRAEGER MEDICAL, INC. |
| K012139 |
07/10/2001 |
VAMOS ANESTHETIC GAS MONITOR |
DRAEGER MEDICAL, INC. |
| K012177 |
07/12/2001 |
VENTVIEW, MODEL 8414095 |
DRAGER MEDIZINTECHNIK GMBH |
| K041956 |
07/21/2004 |
EMG - ESSENTIAL GAS MODULE, MODEL M1013A |
DRAEGET MEDICAL AG & CO. KGAA |
| K972848 |
08/01/1997 |
NARKOMED MRI ANESTHESIA SYSTEM |
DRAEGER MEDICAL, INC. |
| K973051 |
08/15/1997 |
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS |
DRAEGER MEDICAL, INC. |
| K042607 |
09/24/2004 |
PRIMUS US |
DRAEGER MEDICAL, INC. |
| K023289 |
10/02/2002 |
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 |
DRAGER MEDIZINTECHNIK GMBH |
| K963994 |
10/04/1996 |
NARKOMED GS ANESTHESIA SYSTEM |
DRAEGER MEDICAL, INC. |
| K973949 |
10/16/1997 |
PERIOPERATIVE DATA MANAGEMENT SYSTEM |
DRAEGER MEDICAL, INC. |
| K974193 |
11/07/1997 |
NARKOMED ULTRASONIC FLOW SENSOR |
DRAEGER MEDICAL, INC. |
| K971425 |
04/17/1997 |
NARKOMED M ANESTHESIA SYSTEM (M) |
DRAEGER MEDICAL, INC. |
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