The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model 6110c Otophor.
| Device ID | K870272 |
| 510k Number | K870272 |
| Device Name: | MODEL 6110C OTOPHOR |
| Classification | Stimulator, Nerve |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Coats, Md |
| Correspondent | Coats, Md LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-27 |
| Decision Date | 1987-08-05 |