The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Smarttroae.
| Device ID | K023859 |
| 510k Number | K023859 |
| Device Name: | SMARTTROAE |
| Classification | Audiometer |
| Applicant | INTELLIGENT HEARING SYSTEMS 7356 S.W. 48 ST. Miami, FL 33155 |
| Contact | Edward Miskiel |
| Correspondent | Edward Miskiel INTELLIGENT HEARING SYSTEMS 7356 S.W. 48 ST. Miami, FL 33155 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-20 |
| Decision Date | 2003-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020860 | K023859 | 000 |
| 00817020020075 | K023859 | 000 |
| 00817020020051 | K023859 | 000 |
| 00817020021126 | K023859 | 000 |