FDA 510(k) Applications for Medical Device:
Monitor, Ultrasonic, Nonfetal

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K973644 BIOMEDIX, INC. P.O. BOX 1419
CAMDEN NJ 08105
K973857 BIOMEDIX, INC. P.O. BOX 1419
CAMDEN NJ 08105
K943338 BIOSENSOR CORP. 13755 FIRST AVENUE NORTH
PLYMOUTH MN 55441
K070815 G.F. S.R.L. 5 TIMBER LANE
NORTH READING MA 01864
K973336 IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR.
GOLDEN CO 80403
K242487 Laminar Digital Health, Inc. 440 N Wolfe Road
Sunnyvale CA 94085
K052067 MULTIGON INDUSTRIES, INC. ONE ODELL PLAZA
YONKERS NY 10701
K110628 NEWMAN MEDICAL 5350 VIVIAN STREET
Arvada CO 80002
K982635 NICOLET BIOMEDICAL 6355 JOYCE DR.
GOLDEN CO 80403
K010521 NICOLET BIOMEDICAL 6355 JOYCE DR.
GOLDEN CO 80403
K060064 ODVI 69 RUE DE PARIS
ORSAY 91400
K093393 SUMMIT DOPPLER SYSTEMS, INC. 4680 TABLE MOUNTAIN DR #150
GOLDEN CO 80403
K063600 SUMMIT DOPPLER SYSTEMS, INC. 4620 TECHNOLOGY DR. UNIT 100
GOLDEN CO 80403
K141657 THD SPA VIA A. BONETTI 3/A
IMOLA, BO 40026
K081429 THD SPA 5 TIMBER LN.
NORTH READING MA 01864
K090009 THD SPA 5 TIMBER LN.
NORTH READING MA 01864




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