The following data is part of a premarket notification filed by Hangzhou Bever Medical Devices Co., Ltd. with the FDA for Bever Endotracheal Tube, Bever Eva Endotracheal Tube.
| Device ID | K111401 |
| 510k Number | K111401 |
| Device Name: | BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. NO. 8-1, LONGQUAN ROAD CANGQIAN TOWN, YUHANG DISTRICT Hangzhou, Zhejiang, CN 311121 |
| Contact | Allyson Zhou |
| Correspondent | Allyson Zhou HANGZHOU BEVER MEDICAL DEVICES CO., LTD. NO. 8-1, LONGQUAN ROAD CANGQIAN TOWN, YUHANG DISTRICT Hangzhou, Zhejiang, CN 311121 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-19 |
| Decision Date | 2012-07-19 |
| Summary: | summary |