FDA 510(k) Applications Submitted by D H CHANG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K002655 |
08/25/2000 |
DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 |
MEDITEC CO., LTD. |
| K992328 |
07/12/1999 |
FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800 |
MEDITEC CO., LTD. |
| K032630 |
08/26/2003 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES |
KINGSWELL INTERNATIONAL INC. |
| K032668 |
08/28/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES |
KINGSWELL INTERNATIONAL INC. |
| K032670 |
08/29/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR |
KINGSWELL INTERNATIONAL INC. |
| K053354 |
12/02/2005 |
INTERMEZZO PLUS FIXTURE |
MEGAGEN CO., LTD. |
| K053353 |
12/02/2005 |
RESCUE IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
| K052369 |
08/29/2005 |
EXFEEL IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
| K042339 |
08/30/2004 |
NEOPLANT IMPLANT SYSTEM |
NEOBIOTECH CO., LTD. |
| K070562 |
02/27/2007 |
EZ PLUS IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
| K050635 |
03/31/2005 |
ALLFIM IMPLANT SYSTEMS |
COWELL MEDI CO LTD. |
| K051018 |
04/21/2005 |
INTERMEZZO IMPLANT SYSTEMS |
MEGAGEN CO., LTD. |
| K041378 |
05/24/2004 |
BIO 60 |
KODENT, INC. |
| K041655 |
06/18/2004 |
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) |
COWELL MEDI CO LTD. |
| K061797 |
06/26/2006 |
SM IMPLANT SYSTEMS |
DIO DEPARTMENT DSI, INC. |
| K031010 |
03/31/2003 |
MIRACLE 98 |
SB LUCIUS, INC. |
| K021947 |
06/13/2002 |
CERANUM 87 |
LUCIUS METALS COM. |
| K021948 |
06/13/2002 |
LUCIUS 62 |
LUCIUS METALS COM. |
| K023196 |
09/25/2002 |
LUCIUS 76 |
SB LUCIUS, INC. |
| K023197 |
09/25/2002 |
CERANUM 82 |
SB LUCIUS, INC. |
| K023199 |
09/25/2002 |
CERANUM 50 |
SB LUCIUS, INC. |
| K023200 |
09/25/2002 |
CERANUM 76 |
SB LUCIUS, INC. |
| K023198 |
09/25/2002 |
CERANUM 90 |
SB LUCIUS, INC. |
| K024135 |
12/16/2002 |
AIGIS-PLUS |
SB LUCIUS, INC. |
| K024145 |
12/16/2002 |
AIGIS-XO |
SB LUCIUS, INC. |
| K024144 |
12/16/2002 |
AIGIS-PT |
SB LUCIUS, INC. |
| K024143 |
12/16/2002 |
AIGIS-FINE |
SB LUCIUS, INC. |
| K024142 |
12/16/2002 |
AIGIS-SUPER |
SB LUCIUS, INC. |
| K024141 |
12/16/2002 |
NEO 76 |
SB LUCIUS, INC. |
| K024140 |
12/16/2002 |
AIGIS-A |
SB LUCIUS, INC. |
| K024139 |
12/16/2002 |
AIGIS-INLAY |
SB LUCIUS, INC. |
| K024136 |
12/16/2002 |
AIGIS-SOFT |
SB LUCIUS, INC. |
| K210422 |
02/11/2021 |
INTAI Surgical Mask (non-sterile) |
INTAI Technology Corp. |
| K201229 |
05/07/2020 |
Intai Anatomic Locking Plate and Screw System |
Intai Technology Corporation |
| K050620 |
03/10/2005 |
READMYHEART, MODEL RMH3.0 |
DAILYCARE BIOMEDICAL INC |
| K062894 |
09/27/2006 |
INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 |
DAILYCARE BIOMEDICAL INC |
| K052303 |
08/24/2005 |
READMYHEART, MODEL RMH2.0 |
DAILYCARE BIOMEDICAL INC |
| K052732 |
09/29/2005 |
ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P |
ABRACAIR, INC. |
| K102134 |
07/29/2010 |
MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM |
UNITED INTEGRATED SERVICES CO., LTD. |
| K082686 |
09/15/2008 |
MULTI-CHANNEL LASER THERAPY SYSTEM |
UNITED INTEGRATED SERVICES CO., LTD. |
| K120431 |
02/13/2012 |
HALO90 ULTRA ABLATION CATHETER |
BARRX MEDICAL, INC. |
| K140553 |
03/04/2014 |
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS |
INTUITIVE SURGICAL, INC. |
| K172510 |
08/21/2017 |
╡Cor Heart Failure and Arrhythmia Management System |
ZOLL Manufacturing Corporation |
| K112454 |
08/25/2011 |
HALO60 ABLATION CATHETER |
BARRX MEDICAL, INC. |
| K083287 |
11/07/2008 |
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM |
CORVENTIS, INC. |
| K192146 |
08/08/2019 |
V-DENUPET |
Vitromed GmbH |
| K193285 |
11/27/2019 |
V-ONESTEP |
Vitromed GmbH |
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