The following data is part of a premarket notification filed by Smartdata Suzhou Co., Ltd with the FDA for Andorate Auxiliary Water Connector, Andorate Valves Set.
| Device ID | K191231 |
| 510k Number | K191231 |
| Device Name: | Andorate Auxiliary Water Connector, Andorate Valves Set |
| Classification | Endoscope Channel Accessory |
| Applicant | Smartdata Suzhou Co., Ltd 4F, Block 7, 198#, Jinshan Rd Suzhou, CN 215011 |
| Contact | Cindy Ye |
| Correspondent | Thomas Schorre Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155 -3708 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-05-08 |
| Decision Date | 2019-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816734021344 | K191231 | 000 |
| 10816734022976 | K191231 | 000 |
| 10816734022952 | K191231 | 000 |
| 00849771041313 | K191231 | 000 |