FDA 510(k) Applications Submitted by James Chen
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K191705 |
06/26/2019 |
OptikView GUP2103CMI |
The Linden Group Corp |
| K152135 |
07/31/2015 |
Quantitative Electrocardiographic Detector (QED 2000) |
ACME Portable Machines, Inc. |
| K061857 |
06/30/2006 |
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR |
BIO COMPRESSION SYSTEMS, INC. |
| K974498 |
11/28/1997 |
STRATIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K033897 |
12/16/2003 |
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM |
AGA-LINDE HEALTH CARE |
| K182683 |
09/26/2018 |
Z-Robot Patient Positioning System |
Chinan Biomedical Technology, Inc. |
| K980691 |
02/23/1998 |
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K971279 |
04/07/1997 |
VERSION 4 OPERATING SYSTEM SOFTWARE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K992650 |
08/06/1999 |
AIRIS, AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K072666 |
09/21/2007 |
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM |
BIO COMPRESSION SYSTEMS, INC. |
| K984272 |
11/30/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K984274 |
11/30/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K984278 |
11/30/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K984280 |
11/30/1998 |
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
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