The following data is part of a premarket notification filed by Meda Co. Ltd. with the FDA for Bladder Scanner.
| Device ID | K113304 |
| 510k Number | K113304 |
| Device Name: | BLADDER SCANNER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDA CO. LTD. 13505 BROADFIELD DR. Potomac, MD 20854 |
| Contact | Kai Chen |
| Correspondent | Kai Chen MEDA CO. LTD. 13505 BROADFIELD DR. 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 | 2011-11-08 |
| Decision Date | 2012-03-23 |
| Summary: | summary |