FDA 510(k) Applications for Medical Device:
Ophthalmoscope, Ac-Powered
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K131939 | AMICO DIAGNOSTIC INCORPORATED |
445 APOLLO BEACH BLVD. | APOLLO BEACH | FL | 33572 |
| K111531 | ANNIDIS HEALTH SYSTEMS CORP. |
2650 QUEENSVIEW DRIVE | OTTAWA, ONTARIO | K2B 8H6 | |
| K110205 | APPASAMY ASSOCIATES |
20, SBI OFFICERS COLONY | ARUMBAKKAM, CHENNAI | 600 106 | |
| K063343 | BIOPTIGEN, INC. |
719 A ST. NE | WASHINGTON | DC | 20002 |
| K150722 | BIOPTIGEN, INC. |
633 DAVIS DRIVE, SUITE 480 | MORRISVILLE | NC | 27560 |
| K120057 | BIOPTIGEN, INC. |
104 T.W. ALEXANDER DRIVE | DURHAM | NC | 27709 |
| K992606 | CANON U.S.A., INC. |
ONE CANON PLAZA | LAKE SUCCESS | NY | 11042-1198 |
| K063378 | CARL ZEISS MEDITEC INC |
5160 HACIENDA DR. | DUBLIN | CA | 94568 |
| K033123 | CARL ZEISS MEDITEC INC |
5160 HACIENDA DR. | DUBLIN | CA | 94568 |
| K030433 | CARL ZEISS MEDITEC INC |
5160 HACIENDA DR. | DUBLIN | CA | 94568 |
| K051789 | CARL ZEISS MEDITEC INC |
5160 HACIENDA DR. | DUBLIN | CA | 94568 |
| K961171 | CARL ZEISS, INC. |
ONE ZEISS DR. | THORNWOOD | NY | 10594 |
| K133758 | CENTERVUE SPA |
PIAZZA ALBANIA 10 | ROME | 00153 | |
| K994340 | HAI LABORATORIES, INC. |
30 NORTHPOINT RD. | SOUND BEACH | NY | 11789-1734 |
| K971671 | HEIDELBERG ENGINEERING |
TIERGARTENSTRASSE 17 | HEIDELBERG | 69121 | |
| K123316 | HEINE OPTOTECHNIK GMBH & CO. KG. |
KIENTALSTRASSE 7 | HERRSCHING | D-82211 | |
| K060822 | KEELER INSTRUMENTS, INC. |
456 PKWY. | BROOMALL | PA | 19008 |
| K951728 | MIRA, INC. |
87 RUMFORD AVE. | WALTHAM | MA | 02453-3846 |
| K981640 | ODYSSEY OPTICAL SYSTEMS, LLC. |
2710 OAKBROOK LN. | WESTON | FL | 33332 |
| K042885 | OPHTHALMIC TECHNOLOGIES, INC. |
377 RT 17 S | HASBROUCK HEIGHTS | NJ | 07604 |
| K142953 | OptoMedical Technologies GmbH |
Maria-Goeppert-Strasse 1 | Luebeck | 23562 | |
| K042001 | OPTOS PLC |
555 THIRTEENTH ST. N.W. | WASHINGTON | DC | 20004-1109 |
| K983999 | OPTOS PLC |
555 THIRTEENTH ST. N.W. | WASHINGTON | DC | 20004 |
| K103266 | OPTOVUE, INC. |
45531 NORTHPORT LOOP W. | FREMONT | CA | 94538 |
| K133892 | OPTOVUE, INC. |
2800 BAYVIEW DRIVE | FREMONT | CA | 94538 |
| K121739 | OPTOVUE, INC. |
45531 Northport Loop W | FREMONT | CA | 94538 |
| K100861 | OPTOVUE, INC. |
45531 NORTHPORT LOOP W. | FREMONT | CA | 94538 |
| K101505 | OPTOVUE, INC. |
45531 NORTHPORT LOOP W. | FREMONT | CA | 94538 |
| K120238 | OPTOVUE, INC. |
45531 Northport Loop W | FREMONT | CA | 94538 |
| K153080 | OPTOVUE, INC. |
2800 BAYVIEW DRIVE | FREMONT | CA | 94538 |
| K141638 | PROPPER MANUFACTURING CO.,INC. |
36-04 SKILLMAN AVENUE | LONG ISLAND CITY | NY | 11101 |
| K000731 | TALIA TECHNOLOGY LTD. |
COLUMBIA SQUARE | WASHINGTON | DC | 20004-1109 |
| K061674 | TALIA TECHNOLOGY LTD. |
555 THIRTEENTH ST. N.W. | WASHINGTON | DC | 20004-1109 |
| K031312 | TALIA TECHNOLOGY LTD. |
555 THIRTEENTH ST. N.W. | WASHINGTON | DC | 20004-1109 |
| K041290 | TALIA TECHNOLOGY LTD. |
555 THIRTEENTH ST. N.W. | WASHINGTON | DC | 20004-1109 |
| K964137 | TALIA TECHNOLOGY LTD. |
COLUMBIA SQUARE | WASHINGTON | DC | 20004-1109 |
| K003376 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
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