The following data is part of a premarket notification filed by Tianjin Medis Medical Device Co., Ltd. with the FDA for Endotracheal Tube.
| Device ID | K190274 |
| 510k Number | K190274 |
| Device Name: | Endotracheal Tube |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Tianjin Medis Medical Device Co., Ltd. No. 15-A, Saida One Avenue, Xiqing Economic Development Area Tainjin, CN 300385 |
| Contact | Yongzhi Wu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16920687303656 | K190274 | 000 |
| 16920687303632 | K190274 | 000 |
| 16920687303625 | K190274 | 000 |
| 16920687303618 | K190274 | 000 |
| 16920687303595 | K190274 | 000 |