The following data is part of a premarket notification filed by Meda Co.,ltd with the FDA for Md-2300s Ultrasonic A/b Scanner For Ophthalmology.
Device ID | K152318 |
510k Number | K152318 |
Device Name: | MD-2300S Ultrasonic A/B Scanner For Ophthalmology |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | MEDA CO.,LTD F2C,F3D,F4C,F5,F6C,BLDG C2,Xinmao Science Skill Park Huayuan Ind. Area Tianjin, CN 300384 |
Contact | Yusheng Zhang |
Correspondent | Kai Chen Medtech International, Inc. 13505 Broadfield Drive Potomac, MD 20854 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-17 |
Decision Date | 2015-11-17 |
Summary: | summary |