The following data is part of a premarket notification filed by Suzhou Weikang Medical Apparatus Co., Ltd with the FDA for Disposable Tracheal Tube.
| Device ID | K140228 |
| 510k Number | K140228 |
| Device Name: | DISPOSABLE TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD 7TH FL. JINGUI BUSINESS BUIDLING NO. 982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD 7TH FL. JINGUI BUSINESS BUIDLING NO. 982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-30 |
| Decision Date | 2014-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B531ETRC7552 | K140228 | 000 |
| B531ETNC7552 | K140228 | 000 |
| B531ETNC7052 | K140228 | 000 |
| B531ETNC6552 | K140228 | 000 |
| B531ETNC6052 | K140228 | 000 |
| B531ETNC5550 | K140228 | 000 |
| B531ETNC5052 | K140228 | 000 |
| B531ETNC4550 | K140228 | 000 |
| B531ETNC4052 | K140228 | 000 |
| 10812460028671 | K140228 | 000 |
| B531ETNC8052 | K140228 | 000 |
| B531ETNC8552 | K140228 | 000 |
| B531ETNC9052 | K140228 | 000 |
| B531ETRC7052 | K140228 | 000 |
| B531ETNU7552 | K140228 | 000 |
| B531ETNU7052 | K140228 | 000 |
| B531ETNU5552 | K140228 | 000 |
| B531ETNU5052 | K140228 | 000 |
| B531ETNU4552 | K140228 | 000 |
| B531ETNU4052 | K140228 | 000 |
| B531ETNU3552 | K140228 | 000 |
| B531ETNU3052 | K140228 | 000 |
| 10812460027483 | K140228 | 000 |