The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano Ifr Modality.
| Device ID | K133323 |
| 510k Number | K133323 |
| Device Name: | VOLCANO IFR MODALITY |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO CORPORATION 3721 VALLEY CENTRE DR. SUITE 500 San Diego, CA 92130 |
| Contact | Neeta Sharma |
| Correspondent | Neeta Sharma VOLCANO CORPORATION 3721 VALLEY CENTRE DR. SUITE 500 San Diego, CA 92130 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-29 |
| Decision Date | 2014-03-14 |
| Summary: | summary |