The following data is part of a premarket notification filed by Jiangxi Yikang Medical Instrument Group Co., Ltd with the FDA for Yikang Endotracheal Tube.
| Device ID | K190213 |
| 510k Number | K190213 |
| Device Name: | Yikang Endotracheal Tube |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Jiangxi Yikang Medical Instrument Group Co., Ltd 188 Aihua Road, Jinxian County Nanchang, CN 331725 |
| Contact | Nicholas Su |
| Correspondent | Nicholas Su Jiangxi Yikang Medical Instrument Group Co., Ltd 188 Aihua Road, Jinxian County Nanchang, CN 331725 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812460024598 | K190213 | 000 |
| 10812460024109 | K190213 | 000 |
| 10812460024116 | K190213 | 000 |
| 10812460024123 | K190213 | 000 |
| 10812460024154 | K190213 | 000 |
| 30812460024158 | K190213 | 000 |
| 10812460024161 | K190213 | 000 |
| 10812460024499 | K190213 | 000 |
| 10812460024505 | K190213 | 000 |
| 10812460024512 | K190213 | 000 |
| 10812460024529 | K190213 | 000 |
| 10812460024536 | K190213 | 000 |
| 10812460024543 | K190213 | 000 |
| 10812460024550 | K190213 | 000 |
| 10812460024567 | K190213 | 000 |
| 10812460024574 | K190213 | 000 |
| 10812460024581 | K190213 | 000 |
| 10812460024093 | K190213 | 000 |