FDA 510(k) Applications for Medical Device:
Monitor, Ultrasonic, Fetal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K111934 | ADVANCED INSTRUMENTATIONS, INC. |
601 WEST 20 ST | HIALEAH | FL | 33010 |
| K112529 | ADVANCED INSTRUMENTATIONS, INC. |
601 WEST 20 ST | HIALEAH | FL | 33010 |
| K112911 | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
P.O. BOX 237-023 | SHANGHAI | 200237 | |
| K082480 | CONTEC MEDICAL SYSTEM CO., LTD. |
SUITE 8D , ZHONGXIN ZHONGSHAN | ZHONG SHAN, SHANGHAI | 20030 | |
| K220245 | Contec Medical Systems Co., Ltd. |
No.112 Qinhuang West Street, | Qinhuangdao | ||
| K033156 | D. E. HOKANSON, INC. |
12840 N.E. 21ST PL. | BELLEVUE | WA | 98005-1910 |
| K172780 | Edan Instruments Inc |
#15 Jinhui Road,Jinsha Community, Kengzi Sub-District | Shenzhen | 518067 | |
| K153475 | EDAN INSTRUMENTS, INC. |
3/F - B, NANSHAN MEDICAL EQUIPMENT PARK, NANHAI RD 1019# | SHENZHEN | 518067 | |
| K080087 | EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA | YONKERS | NY | 10701 |
| K040480 | EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA | YONKERS | NY | 10701 |
| K140579 | EDAN INSTRUMENTS, INC. |
NANHAI RD 1019 NO. SHEKOU, NANSHAN | SHENZHEN, GUANGDONG | 518067 | |
| K092997 | EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA | YONKERS | NY | 10701 |
| K030466 | ELCAT, GMBH |
1308 MORNINGSIDE PARK DR. | ALPHARETTA | GA | 30022 |
| K191110 | HeraMED Ltd. |
6 Meir Ariel St. | Netanya | 4059300 | |
| K023143 | KOVEN TECHNOLOGY, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K031504 | KOVEN TECHNOLOGY, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K991441 | MEDASONICS, INC. |
9712 S. ALTAMONT DR. | SANDY | UT | 84092 |
| K110630 | MEDIANA CO., LTD. |
1650-1 DONGHWA-RI | WONJU-CITY, GANGWON-DO | 220-801 | |
| K013547 | PMG MEDICA LTD. |
POB 6718 | EFRAT | 90435 | |
| K182190 | Shenzhen AOJ Medical Technology Co., Ltd. |
Room 202, HaoGu Industry Park, 2037 Guanguang Road, | Shenzhen | 518105 | |
| K090510 | SHENZHEN BESTMAN INSTRUMENT CO., LTD. |
KEJI NAN NO.12 RD. | GUANGDONG | ||
| K100626 | SHENZHEN BIOCARE ELECTRONICS CO., LTD |
SUITE 5D, NO 19, LANE 999 | SHANGHAI | 200030 | |
| K082055 | SHENZHEN CREATIVE INDUSTRY CO., LTD |
2/F, BLOCK 3, NANYOU TIAN'AN | SHENZHEN, GUANGDONG | 518054 | |
| K180419 | Shenzhen IMDK Medical Technology Co., Ltd. |
C Zone, 10F, Building16, Yuanshan Industrial B Area | Shenzhen | 518106 | |
| K110124 | SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD |
P.O. BOX 237-023 | SHANGHAI | 200237 | |
| K131457 | SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD |
4TH FLOOR, JINHUI BUILDING, NANHAI BLVD | SHENZHEN, GUANGDONG | 518052 | |
| K212084 | Shenzhen Mericonn Technology Co., Ltd. |
Room 20203, Building 6, Donglongxing Kejiyuan, | Shenzhen | 518109 | |
| K211940 | Shenzhen Taikang Medical Equipment Co., Ltd. |
3F East, Building 4, Lanzhu East Road 8, Grand Industrial | Shenzhen | 518015 | |
| K182710 | ShenzZhen Luckcome Technology Inc., Ltd. |
Floor 6A, 6th Building , Tongfuyu Industrial Park, | Shenzhen | 518055 | |
| K024197 | SUMMIT DOPPLER SYSTEMS, INC. |
5350 VIVIAN ST., SUITE A | ARVADA | CO | 80002-1957 |
| K061091 | THE NEWMAN GROUP, LLC |
935 WEST CHESTNUT ST. | CHICAGO | IL | 60622 |
| K182526 | Vcomin Technology Limited |
2&3 FI., No. 1, Kangzheng Rd., Buji Town | Shenzhen | 518110 |
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