The following data is part of a premarket notification filed by Bioresearch with the FDA for Sonopak/qs, Sonopak.
| Device ID | K905657 |
| 510k Number | K905657 |
| Device Name: | SONOPAK/QS, SONOPAK |
| Classification | Device, Dental Sonography, For Monitoring Jaw Sounds |
| Applicant | BIORESEARCH 4113 NORTH PORT WASHINGTON RD. Milwaukee, WI 53212 |
| Contact | John Radke |
| Correspondent | John Radke BIORESEARCH 4113 NORTH PORT WASHINGTON RD. Milwaukee, WI 53212 |
| Product Code | NFQ |
| CFR Regulation Number | 872.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-17 |
| Decision Date | 1991-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009598218 | K905657 | 000 |
| 00860003499931 | K905657 | 000 |
| 00860003499924 | K905657 | 000 |