The following data is part of a premarket notification filed by Rivanna Medical, Llc with the FDA for Accuro 3000 Ultrasound Scanner.
| Device ID | K132736 |
| 510k Number | K132736 |
| Device Name: | ACCURO 3000 ULTRASOUND SCANNER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | RIVANNA MEDICAL, LLC 1304 STONEGATE CT. Crozet, VA 22932 |
| Contact | William Mauldin |
| Correspondent | William Mauldin RIVANNA MEDICAL, LLC 1304 STONEGATE CT. Crozet, VA 22932 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2014-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B015000010 | K132736 | 000 |