GXX — Block, Test, Ultrasonic Scanner Calibration Class I
FDA product code GXX covers "Block, Test, Ultrasonic Scanner Calibration", a Class I medical device regulated under 21 CFR 882.1925. Submissions are reviewed by the Neurology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXX
- Device Class
- Class I
- Regulation Number
- 882.1925
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K893216 | radiation measurements | RMI ULTRASOUND DOPPLER PHANTOM SYSTEM | September 5, 1989 |
| K844247 | technicare | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS | January 23, 1985 |
| K844120 | echo ultrasound | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS | January 23, 1985 |