FDA 510(k) Applications for Medical Device Product Code "KPJ"
(Chamber, Oxygen, Topical, Extremity)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K002632 |
ADJUNCTIVE THERAPEUTICS, INC. |
OXYGENATOR |
10/25/2001 |
K080966 |
AOTI LTD. |
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM |
08/06/2008 |
K090681 |
ELECTROCHEMICAL OXYGEN CONCEPTS, INC. |
TANSCU O2 |
08/12/2009 |
K971507 |
GWR MEDICAL, LLP |
O2 BOOT |
11/07/1997 |
K112634 |
INOTEC AMD LTD. |
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP |
07/03/2012 |
K050156 |
IYIA TECHNOLOGIES, INC. |
WHS-1000 WOUND HEALING SYSTEM |
06/17/2005 |
K960756 |
LIFETECH SYSTEMS, INC. |
LIFETECH CASSETTE |
08/29/1997 |
K020466 |
METRO MEDICAL EQUIPMENT, INC. |
HEC 1000 |
05/08/2002 |
K120764 |
NEOGENIX, LLC |
EPIFLO(R) |
04/27/2012 |
K190742 |
Neogenix, LLC dba Ogenix |
EPIFLO-28 |
12/13/2019 |
K981949 |
NUMOTECH, INC. |
NUMOBAG |
02/03/1999 |
K023456 |
OXYFAST CORPORATION |
OXYBOX SYSTEM |
02/24/2003 |
K963777 |
STEPHENSON INDUSTRIES, INC. |
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 |
07/28/1997 |
K212121 |
Vaporox, Inc. |
VHT-200 Wound Treatment System |
03/23/2023 |
K022028 |
VASCULAR ONE, INC. |
VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER |
12/17/2002 |
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