The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Janus Atac Eng Analysis System.
| Device ID | K904385 |
| 510k Number | K904385 |
| Device Name: | JANUS ATAC ENG ANALYSIS SYSTEM |
| Classification | Nystagmograph |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Alfred Coats |
| Correspondent | Alfred Coats LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1992-06-10 |