The following data is part of a premarket notification filed by Carenoso Technology Co., Ltd. with the FDA for Padscan Hd Series Bladder Scanner.
| Device ID | K131227 |
| 510k Number | K131227 |
| Device Name: | PADSCAN HD SERIES BLADDER SCANNER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CARENOSO TECHNOLOGY CO., LTD. 4TH FL, NO. 11 BLDG INITIATING ZONE, INSTRUMENTS & METERS INDUSTRY BASE, NEAR PORT INDUSTRY ZONE Dandong, Liaoning, CN 118009 |
| Contact | Zhang Wensheng |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-04-30 |
| Decision Date | 2013-07-12 |
| Summary: | summary |