FDA 510(k) Applications for Medical Device:
Ophthalmoscope, Battery-Powered
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K962767 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K093495 | AMERICAN DIAGNOSTIC CORP. |
55 COMMERCE DR. | HAUPPAUGE | NY | 11788 |
| K142486 | HEINE Optotechnik GmbH & Co. KG |
Kientalstr. 7 | Herrsching | 82211 | |
| K142837 | HEINE Optotechnik GmbH & Co. KG |
Kientalstr. 7 | Herrsching | 82211 | |
| K131961 | HEINE OPTOTECHNIK GMBH & CO. KG. |
KIENTALSTRASSE 7 | HERRSCHING | D-82211 | |
| K123587 | HEINE OPTOTECHNIK GMBH & CO. KG. |
KIENTALSTRASSE 7 | HERRSCHING | D-82211 | |
| K131959 | HEINE OPTOTECHNIK GMBH & CO. KG. |
KIENTALSTRASSE 7 | HERRSCHING | D-82211 | |
| K970029 | KEELER INSTRUMENTS, INC. |
456 PKWY. | BROOMALL | PA | 19008 |
| K032087 | KEELER INSTRUMENTS, INC. |
456 PKWY. | BROOMALL | PA | 19008 |
| K070270 | KIRCHNER & WILHELM GMBH + CO.KG |
55 NORTHERN BLVD, SUITE 200 | GREAT NECK | NY | 11021 |
| K002044 | MAGNA FORTIS CORPORATION |
13606 N.E. 20 ST. | BELLEVUE | WA | 98005 |
| K131719 | MEDICAL DEVICES (PVT) LTD. |
WAZIRABAD RD. | UGOKI-SIALKOT | PK | |
| K061278 | OPHTHALMOS LTD. |
UNIT 1 ABBEY BARNS | ICKLETON, CAMBRIDGE | CB10 1SX | |
| K053425 | PRECISION OPTICS CORP. |
22 EAST BROADWAY | GARDNER | MA | 01440-3338 |
| K052599 | SUZHOU 66 VISION TECH CO., LTD. |
600/8/503 LIUZHOU ROAD | SHANGHAI | 200233 |
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