FDA 510(k) Applications for Medical Device:
Device, Biofeedback
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K012384 |
BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA
| MUNDELEIN |
IL |
60060-3700 |
K983550 |
BIO-MONITORING INTERNATIONAL CORP. |
55 Northern Blvd.
| Great Neck |
NY |
11021 |
K990538 |
BRAINMASTER |
55 NORTHERN BLVD., SUITE 200
| GREAT NECK |
NY |
11021 |
K972487 |
CHATTANOOGA GROUP, INC. |
4717 ADAMS RD.
| HIXSON |
TN |
37343-0489 |
K073557 |
CORSCIENCE GMBH & CO. KG |
HENKESTRASSE 91
| ERLANGEN |
|
91052 |
K953257 |
CYCURA CORP. |
P.O. BOX 364
| ROCKLIN |
CA |
95677 |
K981934 |
DELSYS, INC. |
PO BOX 15734
| BOSTON |
MA |
02215 |
K990356 |
DELSYS, INC. |
PO BOX 15734
| BOSTON |
MA |
02215 |
K961718 |
DISCOVERY ENGINEERING INTL., INC. |
3115 WESTWOOD DR.
| TOPEKA |
KS |
66614-2741 |
K122879 |
EEG SOFTWARE LLC |
17625 MAYALL STREET
| NORTHRIDGE |
CA |
91325 |
K971400 |
ENRICHING YOUR LIFE |
6339 KELLY DR.
| GRANBURY |
TX |
76048 |
K011983 |
FASSTECH |
155 MIDDLESEX TURNPIKE
| BURLINGTON |
MA |
01803 |
K990778 |
FASSTECH |
155 MIDDLESEX TURNPIKE
| BURLINGTON |
MA |
01803 |
K011964 |
FASSTECH |
155 MIDDLESEX TURNPIKE
| BURLINGTON |
MA |
01803 |
K222101 |
GrayMatters Health Ltd. |
82 HaÆ Atzmaut Street
| Haifa |
|
|
K000405 |
INTERCURE LTD. |
555 13TH ST. N.W.
| WASHINGTON |
DC |
20004-1109 |
K020399 |
INTERCURE LTD. |
555 13TH ST. N.W.
| WASHINGTON |
DC |
20004-1109 |
K971708 |
J & J ENGINEERING, INC. |
55 NORTHERN BLVD., SUITE 410
| GREAT NECK |
NY |
11021 |
K954737 |
J-TECH, INC. |
50 WEST CANYON RD.
| ALPINE |
UT |
84004 |
K071866 |
KCBIOMEDIX, INC. |
4200 SW SAPELO DR.
| LEES SUMMIT |
MO |
64082 |
K961645 |
LEXICOR MEDICAL TECHNOLOGY, INC. |
5589 ARAPAHOE AVE., #206
| BOULDER |
CO |
80303 |
K092675 |
MEDOTECH A/S |
13417 QUIVAS ST
| WESTMINSTER |
CO |
80234 |
K041244 |
MEDTRONIC VASCULAR |
4000 LEXINGTON AVE., NORTH
| SHOREVIEW |
MN |
55126-2893 |
K963202 |
MEGA ELECTRONICS LTD. |
1660 RIVERTON POINT
| EAGAN |
MN |
55122 |
K972723 |
MINDMEDIA LABS, INC. |
1036 WILLA LAKE CIRCLE
| OVEIDA |
FL |
32765 |
K111687 |
MYOTRONICS-NOROMED, INC. |
5870 S. 194TH ST.
| KENT |
WA |
98032-2126 |
K013399 |
MYOTRONICS-NOROMED, INC. |
15425 53RD AVE. SOUTH
| TUKWILA |
WA |
98188 |
K992439 |
MYOTRONICS-NOROMED, INC. |
15425 53RD AVE. SOUTH
| TUKWILA |
WA |
98188 |
K993654 |
NEUROCYBERNETICS |
55 Northern Blvd.
| Great Neck |
NY |
11021 |
K143507 |
NFANT Labs, LLC |
817 West Peachtree St
| Atlanta |
GA |
30308 |
K011823 |
NICOLET BIOMEDICAL, INC. |
800 LEVANGER LN.
| STOUGHTON |
WI |
53589 |
K010388 |
OHMEDA MEDICAL |
8880 GORMAN RD.
| LAUREL |
MD |
20723 |
K131586 |
PALO ALTO HEALTH SCIENCES, INC. |
755 N MATHILDA AVE
| SUNNYVALE |
CA |
94085 |
K180173 |
Palo Alto Health Sciences, Inc. |
12020 113th Ave NE, Building C, Suite 215
| Kirkland |
WA |
98034 |
K151050 |
Power Medical Devices, LLC |
1615 S.Congress Ave, Ste 13
| Delray Beach |
FL |
33445 |
K943535 |
REGULATORY STRATEGIES, INC. |
1660 RIVERTON POINT
| EAGAN |
MN |
55122 |
K981844 |
RMP, INC. |
601 THIRTEENTH STREET, N.W.
| WASHINGTON |
DC |
20005 |
K970051 |
SMITH AND NEPHEW DONJOY, INC. |
2777 LOKER AVENUE WEST
| CARSBAD |
CA |
92008-6601 |
K003367 |
SRS MEDICAL SYSTEMS, INC. |
14950 N.E. 95TH ST.
| REDMOND |
WA |
98052 |
K003127 |
SRS MEDICAL SYSTEMS, INC. |
14950 N.E. 95TH ST.
| REDMOND |
WA |
98052 |
K965006 |
STOELTING CO. |
620 WHEAT LN.
| WOOD DALE |
IL |
60191 |
K952797 |
STOELTING CO. |
620 WHEAT LN.
| WOOD DALE |
IL |
60191 |
K012011 |
STOELTING CO. |
620 WHEAT LN.
| WOOD DALE |
IL |
60191 |
K163448 |
SUNSTAR SUISSE S.A. |
Route de Pallatex 11
| Etoy |
|
1163 |
K071661 |
TELEDIAGNOSTIC SYSTEMS, INC. |
2484 OLD MIDDLEFIELD WAY
| MOUNTAIN VIEW |
CA |
94043 |
K924313 |
THE JAYMS CO. |
432 NORTH 750 EAST
| LINDON |
UT |
84042 |
K973537 |
THE PROMETHEUS GROUP |
2 MALLARDS COVE
| DUXBURY |
MA |
02332 |
K960761 |
THE PROMETHEUS GROUP |
2 MALLARDS COVE
| DUXBURY |
MA |
02332 |
K960762 |
THE PROMETHEUS GROUP |
2 MALLARDS COVE
| DUXBURY |
MA |
02332 |
K980373 |
ULTRAMIND INTERNATIONAL LTD. |
117 AHUZAH ST.
| RA'ANANNA |
|
43373 |
|
|