ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
FDA 510(k) clearance K844120 · decided 1985-01-23
Clearance details
- K-number
- K844120
- Device name
- ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
- Applicant
- Echo Ultrasound
- Decision
- Substantially Equivalent
- Date received
- 1984-10-23
- Decision date
- 1985-01-23
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- GXX
- Device class
- 1
- Regulation number
- 882.1925
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- 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 |
|---|---|---|
| RMI ULTRASOUND DOPPLER PHANTOM SYSTEM (K893216) | Radiation Measurements, Inc. | 1989-09-05 |
| ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS (K844247) | Technicare Corp. | 1985-01-23 |
Recalls involving this device
No recalls on record reference this clearance.