The following data is part of a premarket notification filed by Intl. Acoustics, Inc. with the FDA for Iai Program-computer Program.
| Device ID | K844997 |
| 510k Number | K844997 |
| Device Name: | IAI PROGRAM-COMPUTER PROGRAM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | INTL. ACOUSTICS, INC. 1250 W. NORTHWEST HIGHWAY, SUITE 720 Palatine, IL 60067 |
| Contact | Gerald A Kien |
| Correspondent | Gerald A Kien INTL. ACOUSTICS, INC. 1250 W. NORTHWEST HIGHWAY, SUITE 720 Palatine, IL 60067 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-26 |
| Decision Date | 1985-04-09 |