The following data is part of a premarket notification filed by Artifical Hearing Systems Corp. with the FDA for Intelligent Visual Reinforcement Audiometry (ivra).
| Device ID | K900096 |
| 510k Number | K900096 |
| Device Name: | INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) |
| Classification | Audiometer |
| Applicant | ARTIFICAL HEARING SYSTEMS CORP. 1125 N.E. 125 STREET, SUITE 206 North Miami, FL 33161 |
| Contact | Edward Miskiel |
| Correspondent | Edward Miskiel ARTIFICAL HEARING SYSTEMS CORP. 1125 N.E. 125 STREET, SUITE 206 North Miami, FL 33161 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-08 |
| Decision Date | 1990-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020952 | K900096 | 000 |
| 00817020020334 | K900096 | 000 |
| 00817020020341 | K900096 | 000 |
| 00817020020358 | K900096 | 000 |
| 00817020020365 | K900096 | 000 |
| 00817020020372 | K900096 | 000 |
| 00817020020389 | K900096 | 000 |
| 00817020020396 | K900096 | 000 |
| 00817020020402 | K900096 | 000 |
| 00817020020419 | K900096 | 000 |
| 00817020020785 | K900096 | 000 |
| 00817020020877 | K900096 | 000 |
| 00817020020884 | K900096 | 000 |
| 00817020020327 | K900096 | 000 |