ELECTROSONOGRAM ESG-1
FDA 510(k) clearance K905449 · decided 1991-04-26
Clearance details
- K-number
- K905449
- Device name
- ELECTROSONOGRAM ESG-1
- Applicant
- Myo-Tronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-05
- Decision date
- 1991-04-26
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- NFQ
- Device class
- 1
- Regulation number
- 872.2050
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Seattle, WA, 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 |
| SONOPAK/QS, SONOPAK (K905657) | Bioresearch | 1991-05-15 |
| ARTHROPHONOMETER (K862286) | Arthrotek, Inc. | 1987-01-07 |
Recalls involving this device
No recalls on record reference this clearance.