RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
FDA 510(k) clearance K893216 · decided 1989-09-05
Clearance details
- K-number
- K893216
- Device name
- RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
- Applicant
- Radiation Measurements, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-27
- Decision date
- 1989-09-05
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- GXX
- Device class
- 1
- Regulation number
- 882.1925
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Middleton, 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 |
|---|---|---|
| ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS (K844120) | Echo Ultrasound | 1985-01-23 |
| ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS (K844247) | Technicare Corp. | 1985-01-23 |
Recalls involving this device
No recalls on record reference this clearance.