SONOCARE
FDA 510(k) clearance K844034 · decided 1985-01-23
Clearance details
- K-number
- K844034
- Device name
- SONOCARE
- Applicant
- Echo Ultrasound
- Decision
- Substantially Equivalent
- Date received
- 1984-10-16
- Decision date
- 1985-01-23
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- DYO
- Device class
- 1
- Regulation number
- 872.5410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lewistown, PA, 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 |
|---|---|---|
| DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD (K935152) | Dentauraum, Inc. | 1994-01-31 |
| STAINLESS STEEL ORTHODONTIC PRODUCTS (K931980) | Ortho Organizers, Inc. | 1993-09-01 |
Recalls involving this device
No recalls on record reference this clearance.