The following data is part of a premarket notification filed by Intl. Acoustics, Inc. with the FDA for Ds-ii Digital Sonography System.
| Device ID | K864278 |
| 510k Number | K864278 |
| Device Name: | DS-II DIGITAL SONOGRAPHY SYSTEM |
| Classification | Stethoscope, Electronic |
| Applicant | INTL. ACOUSTICS, INC. 1250 W. NORTHWEST HIGHWAY, SUITE 720 Palatine, IL 60067 |
| Contact | Gerald Kien |
| Correspondent | Gerald Kien INTL. ACOUSTICS, INC. 1250 W. NORTHWEST HIGHWAY, SUITE 720 Palatine, IL 60067 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-30 |
| Decision Date | 1987-06-10 |