The following data is part of a premarket notification filed by Caresono Technology Co., Ltd. with the FDA for Bladder Scanner.
| Device ID | K153581 |
| 510k Number | K153581 |
| Device Name: | Bladder Scanner |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Caresono Technology Co., Ltd. 4th Floor, No.11 Building Initiating Zone Instruments And Meters Industry Base,Near Port Industry Zone Dangdong, TW 118009 |
| Contact | Yuzhong Ma |
| Correspondent | Long Yang SHENZHEN HLONGMED BIOTECH COMPANY R15-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROAD, NANSHAN DISTRICT Shenzhen, CN 518054 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-15 |
| Decision Date | 2016-04-08 |
| Summary: | summary |