The following data is part of a premarket notification filed by Chilecom Medical Devices Co., Ltd. with the FDA for Endotracheal Tube.
| Device ID | K080105 |
| 510k Number | K080105 |
| Device Name: | ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | CHILECOM MEDICAL DEVICES CO., LTD. 155 FLEMINGTON CT. La Mirada, CA 90638 |
| Contact | Brandon Choi |
| Correspondent | Brandon Choi CHILECOM MEDICAL DEVICES CO., LTD. 155 FLEMINGTON CT. La Mirada, CA 90638 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2009-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B531ETPOU5062 | K080105 | 000 |
| B531ETPNC6562 | K080105 | 000 |
| B531ETPNC7062 | K080105 | 000 |
| B531ETPNC7562 | K080105 | 000 |
| B531ETPOC4062 | K080105 | 000 |
| B531ETPOC4560 | K080105 | 000 |
| B531ETPOC5062 | K080105 | 000 |
| B531ETPOC5562 | K080105 | 000 |
| B531ETPOC6062 | K080105 | 000 |
| B531ETPOC6562 | K080105 | 000 |
| B531ETPOC7062 | K080105 | 000 |
| B531ETPOC7562 | K080105 | 000 |
| B531ETPOC8062 | K080105 | 000 |
| B531ETPOU3062 | K080105 | 000 |
| B531ETPOU3562 | K080105 | 000 |
| B531ETPOU4062 | K080105 | 000 |
| B531ETPOU4562 | K080105 | 000 |
| B531ETPNC6062 | K080105 | 000 |