510(k) K905657
K905657 is an FDA 510(k) premarket notification submitted by Bioresearch for the device "SONOPAK/QS, SONOPAK". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code NFQ (Device, Dental Sonography, For Monitoring Jaw Sounds), a Class I device regulated under 21 CFR 872.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1991
- Date Received
- December 17, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Dental Sonography, For Monitoring Jaw Sounds
- Device Class
- Class I
- Regulation Number
- 872.2050
- Review Panel
- DE
- Submission Type