The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Contact Emg Rotatable Endotracheal Tube.
| Device ID | K050162 |
| 510k Number | K050162 |
| Device Name: | CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE |
| Classification | Stimulator, Nerve |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | David S Dodd |
| Correspondent | David S Dodd MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-25 |
| Decision Date | 2005-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169789579 | K050162 | 000 |
| 00643169789562 | K050162 | 000 |
| 00643169789555 | K050162 | 000 |
| 00763000745868 | K050162 | 000 |
| 00763000745851 | K050162 | 000 |
| 00763000745844 | K050162 | 000 |