FDA 510(k) Applications for Medical Device:
Non-Normalizing Quantitative Electroencephalograph Software
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K952347 | ASPECT MEDICAL SYSTEMS, INC. |
2 VISION DR. | NATICK | MA | 01760-2059 |
| K082886 | BRAINSCOPE COMPANY, INC. |
1717 RHODE ISLAND AVE. | WASHINGTON | DC | 20036 |
| K030489 | BRAINZ INSTRUMENTS LTD. |
25 CARBINE ROAD MT. WELLINGTON | AUCKLAND | ||
| K033010 | BRAINZ INSTRUMENTS LTD. |
25 CARBINE ROAD MT. WELLINGTON | AUCKLAND | ||
| K190760 | Cadwell Industries, Inc. |
909 N. Kellogg Street | Kennewick | WA | 99336 |
| K000068 | COMPUMEDICS NEURO SCIENCE PTY LTD. |
6470 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K000892 | DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K142064 | EB NEURO, S.P.A. |
9001 WESLEYAN RD, STE 200 | INDIANAPOLIS | IN | 46268 |
| K131882 | ELECTRICAL GEODESICS, INC. |
29611 SIMMONS ROAD | EUGENE | OR | 97405 |
| K063797 | ELECTRICAL GEODESICS, INCORPORATED |
29611 SIMMONS ROAD | EUGENE | OR | 97405 |
| K051883 | GE HEALTHCARE |
86 PILGRIM ROAD | NEEDHAM | MA | 02492 |
| K191322 | GE Healthcare Finland Oy |
Kuortaneenkatu 2 | Helsinki | FI-00510 | |
| K072382 | INFINITE BIOMEDICAL TECHNOLOGIES |
3600 CLIPPER MILL ROAD | BALTIMORE | MD | 21211 |
| K091963 | INFINITE BIOMEDICAL TECHNOLOGIES, LLC |
3600 CLIPPER MILL ROAD | BALTIMORE | MD | 21211 |
| K123665 | KVIKNA EHF |
1468 HARWELL AVE | CROFTON | MD | 21114 |
| K143487 | KVIKNA EHF |
STORHOFOI 21 | REYKJAVIK | 110 | |
| K954157 | MEDELEC LTD. |
MANOR WAY | OLD WOKING, SURREY | GU22 9JU | |
| K192572 | Moberg Research, Inc. |
224 S. Maple Street | Ambler | PA | 19002 |
| K001564 | NEURO SCAN LABS |
5700 CROMO DR., SUITE 100 | EL PASO | TX | 79912-5538 |
| K001324 | NEURO SCAN LABS |
5700 CROMO DR., SUITE 100 | EL PASO | TX | 79912-5538 |
| K141316 | NEURONETRIX SOLUTIONS |
816 CONGRESS AVENUE, SUITE 1400 | AUSTIN | TX | 78701 |
| K023536 | NEUROSCAN |
7850 PASEO DEL NORTE | EL PASO | TX | 79912 |
| K133995 | NEUROSOFT LTD |
VIA MARZIA N. 9 | ABANO TERME, PADOVA | 35031 | |
| K220254 | Neurosoft Ltd. |
5, Voronin str. | Ivanovo | 153032 | |
| K062533 | NEUROVIRTUAL USA, INC. |
2315 NW 107TH AVE. | DORAL | FL | 33172 |
| K142834 | NeuroWave Systems Inc. |
2490 Lee Blvd, Suite 300 | Cleveland Heights | OH | 44118 |
| K080546 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K213299 | Pascall Systems Inc |
200 Portland St | Boston | MA | 02114 |
| K991012 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K955577 | STELLATE SYSTEMS |
345 VICTORIA AVE., SUITE 505 | CANADA, H32 2N2 | ||
| K982351 | STELLATE SYSTEMS |
345 VICTORIA AVE., SUITE 505 | CANADA, H32 2N2 |
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