COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST
FDA 510(k) clearance K910212 · decided 1991-07-11
Clearance details
- K-number
- K910212
- Device name
- COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST
- Applicant
- Acoustic Imaging Technologies Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-15
- Decision date
- 1991-07-11
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- JYO
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Phoenix, AZ, 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 |
|---|---|---|
| EAR KNIFE-VARIOUS (K841006) | Premier Dental Products Co. | 1984-05-30 |
| EAR KNIVES (K840764) | Sharpoint, Inc. | 1984-05-21 |
| ROLLER KNIFE-TRANSVERSE -SAGITTAL (K833602) | Microtek Medical, Inc. | 1984-01-03 |
| KNIFE BLADE TIP (K823911) | Treace Medical, Inc. | 1983-01-21 |
| MYRINGOTOMY KNIFE (K772384) | Edward Weck, Inc. | 1978-01-17 |
| ROLLER KNIFE (K772372) | Edward Weck, Inc. | 1978-01-17 |
Recalls involving this device
No recalls on record reference this clearance.