The following data is part of a premarket notification filed by Rln Systems, Inc. with the FDA for Laryngeal Surface Electrode-endotracheal Tube, M-500-et, Lse-et.
| Device ID | K003745 |
| 510k Number | K003745 |
| Device Name: | LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET |
| Classification | Stimulator, Nerve |
| Applicant | RLN SYSTEMS, INC. 2019 HONEYSUCKLE LN. P.O. BOX 6757 Jefferson City, MO 65109 |
| Contact | J. Lee Rea |
| Correspondent | J. Lee Rea RLN SYSTEMS, INC. 2019 HONEYSUCKLE LN. P.O. BOX 6757 Jefferson City, MO 65109 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-04 |
| Decision Date | 2001-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B006LSE600MSP52 | K003745 | 000 |
| SCKITMS5 | K003745 | 000 |
| B006EAKITM1 | K003745 | 000 |
| B006EAKITMSP1 | K003745 | 000 |
| B006DCKITL52 | K003745 | 000 |
| B006DCKITS52 | K003745 | 000 |
| B006LSE500DCL52 | K003745 | 000 |
| B006LSE500DCS52 | K003745 | 000 |
| B006LSE500M52 | K003745 | 000 |
| B006LSE500MSIT52 | K003745 | 000 |
| B006LSE600M52 | K003745 | 000 |
| SCKITM5 | K003745 | 000 |