FDA 510(k) Applications Submitted by RICHARD KEEN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K960072 |
01/05/1996 |
SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX |
BIOCHEM IMMUNOSYSTEMS (U.S.), INC. |
| K990058 |
01/07/1999 |
QMS MAPPING SYSTEM,MODEL 2000 |
CATHDATA, INC. |
| K030061 |
01/07/2003 |
PS 3000 DIGATAL PHOTOSPOT SYSTEM |
PRECISE OPTICS |
| K050239 |
02/02/2005 |
EMD THERMOGRAPHY SYSTEM |
EM DIAGNOSTICS, INC. |
| K061123 |
04/24/2006 |
PALM ECG RECORDER, MODEL EP-201/202 |
PARAMA-TECH COMPANY., LTD |
| K061418 |
05/22/2006 |
QUANTIVA |
TOMOGRAPHIX IP LTD. |
| K051875 |
07/11/2005 |
BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS |
MEDITECH INTERNATIONAL, INC. |
| K041885 |
07/12/2004 |
BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS |
MEDITECH INTERNATIONAL, INC. |
| K051961 |
07/19/2005 |
WWMED, MODEL 401 |
WONG WAY CORPORATION |
| K072551 |
09/10/2007 |
LD-I 75 AND LD-I 200 |
MEDITECH INTERNATIONAL, INC. |
| K122763 |
09/10/2012 |
PHYSIOLOGICAL DATA PROCESSOR |
ZEPHYR TECHNOLOGY CORPORATION |
| K102917 |
10/01/2010 |
FIXTEMP C&B |
EXACTA DENTAL DIRECT, INC |
| K113045 |
10/13/2011 |
BIOHARNESS |
ZEPHYR TECHNOLOGY CORPORATION |
| K003364 |
10/27/2000 |
VIVO 200 DPS VIVOSCAN |
VIVOSONIC, INC. |
| K023621 |
10/29/2002 |
BIOFLEX PROFESSIONAL THERAPY SYSTEM |
MEDITECH INTERNATIONAL, INC. |
| K023726 |
11/06/2002 |
TENS PRO 900 |
ACUMED MEDICAL SUPPLIES, LTD. |
| K123658 |
11/28/2012 |
BIOMODULE 3-M1 |
ZEPHYR TECHNOLOGY CORPORATION |
| K053427 |
12/08/2005 |
FRESH, DENTAL IMPRESSION MATERIAL |
EXACTA DENTAL PRODUCTS, INC. |
| K133789 |
12/12/2013 |
DOLPHIN NEUROSTIM OTC |
ACUMED MEDICAL LTD. |
| K004008 |
12/26/2000 |
STRESS GUARD, MODEL HERDEV1 |
HERBO MEDEX INTERNATIONAL, INC. |
| K955891 |
12/29/1995 |
CARDIOVIEW TRANSTELEPHONIC SOFTWARE |
MICROMEDICAL, INC. |
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