FDA 510(k) Applications for Medical Device:
Amplitude-Integrated Electroencephalograph
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K081551 | ASTRO-MED, INC. |
600 EAST GREENWICH AVE. | WEST WARWICK | RI | 02893 |
| K071449 | BRAINZ INSTRUMENTS LTD. |
25 CARBINE ROAD MT. WELLINGTON | AUCKLAND | ||
| K161027 | Cadwell Industries, Inc. |
909 N. Kellog St. | Kennewick | WA | 99336 |
| K192889 | eemagine Medical Imaging Solutions GmbH |
Gubener Str. 47 | Berlin | D-10243 | |
| K123079 | EXCEL-TECH LTD. (XLTEK) |
2568 BRISTOL CIR. | OAKVILLE, ONTARIO | L6H 5S1 | |
| K131789 | MENNEN MEDICAL LTD. |
4 HAYARDEN ST., YAVNE | REHOVOT | 76100 | |
| K080217 | MOBERG RESEARCH, INC. |
224 S. MAPLE WAY | AMBLER | PA | 19002 |
| K152301 | Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
2568 Bristol Circle | Oakville | L6H5S1 | |
| K093949 | NATUS MEDICAL, INC. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K120485 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K092573 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K130238 | NIHON KOHDEN CORP. |
13721 VIA TRES VISTA | SAN DIEGO | CA | 92129 |
| K163644 | Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuku-Ku | Tokyo | 161-8560 | |
| K031149 | OLYMPIC MEDICAL CORP. |
5900 FIRST AVE., SOUTH | SEATTLE | WA | 98108 |
| K983229 | OLYMPIC MEDICAL CORP. |
5900 FIRST AVE., SOUTH | SEATTLE | WA | 98108 |
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