The following data is part of a premarket notification filed by Micro Audiometrics Corp. with the FDA for Earscan Dsp-1 Pure Tone Audiometer.
| Device ID | K913589 |
| 510k Number | K913589 |
| Device Name: | EARSCAN DSP-1 PURE TONE AUDIOMETER |
| Classification | Audiometer |
| Applicant | MICRO AUDIOMETRICS CORP. 2200 SO. RIDGEWOOD AVENUE, US#1 South Daytona, FL 32119 |
| Contact | Larry Dedernardo |
| Correspondent | Larry Dedernardo MICRO AUDIOMETRICS CORP. 2200 SO. RIDGEWOOD AVENUE, US#1 South Daytona, FL 32119 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-12 |
| Decision Date | 1991-11-05 |