The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Neuroguard Transcranial Doppler Ultrasound System.
| Device ID | K962796 |
| 510k Number | K962796 |
| Device Name: | NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDASONICS, INC. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Contact | William E Mckay |
| Correspondent | William E Mckay MEDASONICS, INC. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-18 |
| Decision Date | 1997-01-21 |