The following data is part of a premarket notification filed by Sensory Aids Corp. with the FDA for Playtone Audiometer.
| Device ID | K872042 |
| 510k Number | K872042 |
| Device Name: | PLAYTONE AUDIOMETER |
| Classification | Audiometer |
| Applicant | SENSORY AIDS CORP. 205 WEST GRAND AVENUE, SUITE 122 Bensenville, IL 60106 |
| Contact | Ron B Merrick |
| Correspondent | Ron B Merrick SENSORY AIDS CORP. 205 WEST GRAND AVENUE, SUITE 122 Bensenville, IL 60106 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-27 |
| Decision Date | 1987-08-11 |