The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Smartoae.
| Device ID | K964426 |
| 510k Number | K964426 |
| Device Name: | SMARTOAE |
| Classification | Audiometer |
| Applicant | INTELLIGENT HEARING SYSTEMS 10689 N. KENDALL DR. SUITE 315 North Miami, FL 33176 |
| Contact | Edward Miskiel |
| Correspondent | Edward Miskiel INTELLIGENT HEARING SYSTEMS 10689 N. KENDALL DR. SUITE 315 North Miami, FL 33176 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-05 |
| Decision Date | 1997-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020853 | K964426 | 000 |