The following data is part of a premarket notification filed by Sonomed, Inc. with the FDA for Master-vu A-scan, Mv4500.
| Device ID | K100252 |
| 510k Number | K100252 |
| Device Name: | MASTER-VU A-SCAN, MV4500 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOMED, INC. 1979 MARCUS AVE. SUITE 105C Lake Success, NY 11040 |
| Contact | Charles O'neal |
| Correspondent | Charles O'neal SONOMED, INC. 1979 MARCUS AVE. SUITE 105C Lake Success, NY 11040 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-28 |
| Decision Date | 2010-04-09 |
| Summary: | summary |