The following data is part of a premarket notification filed by Intl. Acoustics, Inc. with the FDA for Dsp100 Carotid Phonoangiography Module.
| Device ID | K864429 |
| 510k Number | K864429 |
| Device Name: | DSP100 CAROTID PHONOANGIOGRAPHY MODULE |
| Classification | Phonocardiograph |
| Applicant | INTL. ACOUSTICS, INC. 1250 W. NORTHWEST HIGHWAY, SUITE 720 Palatine, IL 60067 |
| Contact | Kien, Phd |
| Correspondent | Kien, Phd INTL. ACOUSTICS, INC. 1250 W. NORTHWEST HIGHWAY, SUITE 720 Palatine, IL 60067 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-12 |
| Decision Date | 1987-05-12 |