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




Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact