The following data is part of a premarket notification filed by Escalon Medical Corp. with the FDA for Vascuview Ultrasound System.
| Device ID | K080049 |
| 510k Number | K080049 |
| Device Name: | VASCUVIEW ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ESCALON MEDICAL CORP. 2440 SOUTH 179TH ST. New Berlin, WI 53146 |
| Contact | Mark Wallace |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-01-08 |
| Decision Date | 2008-01-23 |
| Summary: | summary |