SONOPAK/QS, SONOPAK
FDA 510(k) clearance K905657 · decided 1991-05-15
Clearance details
- K-number
- K905657
- Device name
- SONOPAK/QS, SONOPAK
- Applicant
- Bioresearch
- Decision
- Substantially Equivalent
- Date received
- 1990-12-17
- Decision date
- 1991-05-15
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- NFQ
- Device class
- 1
- Regulation number
- 872.2050
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ESG-1 ELECTROSONOGRAM (ESG-1) (K970116) | Myo-Tronics, Inc. | 1997-04-02 |
| ELECTROSONOGRAM ESG-1 (K905449) | Myo-Tronics, Inc. | 1991-04-26 |
| ARTHROPHONOMETER (K862286) | Arthrotek, Inc. | 1987-01-07 |
Recalls involving this device
No recalls on record reference this clearance.