The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Danplex Screening Audiometer.
Device ID | K923074 |
510k Number | K923074 |
Device Name: | DANPLEX SCREENING AUDIOMETER |
Classification | Audiometer |
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 | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-25 |
Decision Date | 1992-09-23 |