JT-3 ELECTROGNATHOGRAPH
FDA 510(k) clearance K952218 · decided 1995-09-21
Clearance details
- K-number
- K952218
- Device name
- JT-3 ELECTROGNATHOGRAPH
- Applicant
- Bio-Research Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-11
- Decision date
- 1995-09-21
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- NFS
- Device class
- 1
- Regulation number
- 872.2060
- 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 |
|---|---|---|
| SIROGNATHOGRAPH (K843951) | Siemens Medical Solutions USA, Inc. | 1984-11-14 |
Recalls involving this device
No recalls on record reference this clearance.