The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Invotec Laryngeal Electrode.
| Device ID | K122040 |
| 510k Number | K122040 |
| Device Name: | INVOTEC LARYNGEAL ELECTRODE |
| Classification | Stimulator, Nerve |
| Applicant | INVOTEC INTERNATIONAL, INC. 6833 PHILLIPS INDUSTRIAL BLVD. Jacksonville, FL 32256 -3029 |
| Contact | Jeffrey L Aull |
| Correspondent | Jeffrey L Aull INVOTEC INTERNATIONAL, INC. 6833 PHILLIPS INDUSTRIAL BLVD. Jacksonville, FL 32256 -3029 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-12 |
| Decision Date | 2013-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818501020048 | K122040 | 000 |
| 10818501020031 | K122040 | 000 |
| 10818501020024 | K122040 | 000 |