The following data is part of a premarket notification filed by Etymonic Design, Inc. with the FDA for Audioscan(tm) Real Ear Measurement System Rm500.
| Device ID | K884046 |
| 510k Number | K884046 |
| Device Name: | AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | ETYMONIC DESIGN, INC. 41 BYRON AVE. Dorchester, Ontario, CA Nol 1go |
| Contact | Cole |
| Correspondent | Cole ETYMONIC DESIGN, INC. 41 BYRON AVE. Dorchester, Ontario, CA Nol 1go |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1989-02-13 |