The following data is part of a premarket notification filed by Echo Ultrasound with the FDA for Ultrasonic Scanner Calibration & Test Objects.
| Device ID | K844120 |
| 510k Number | K844120 |
| Device Name: | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS |
| Classification | Block, Test, Ultrasonic Scanner Calibration |
| Applicant | ECHO ULTRASOUND POST OFFICE BOX 552 Lewistown, PA 17044 |
| Contact | Russell W Woods |
| Correspondent | Russell W Woods ECHO ULTRASOUND POST OFFICE BOX 552 Lewistown, PA 17044 |
| Product Code | GXX |
| CFR Regulation Number | 882.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1985-01-23 |