The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Danplex Diagnostic Audiometer, Clin. Diag. Audiomt.
| Device ID | K923071 |
| 510k Number | K923071 |
| Device Name: | DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT |
| Classification | Hearing Aid, Air Conduction |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Alfred C Coats |
| Correspondent | Alfred C Coats LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-25 |
| Decision Date | 1992-09-28 |