The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Core Control Pad, Core Series Sw V3.4 Installation Kit, Core, Core Mobile.
| Device ID | K133641 |
| 510k Number | K133641 |
| Device Name: | CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO CORPORATION 1 FORTUNE DR Billerica, MA 01821 |
| Contact | Marcus Garcia |
| Correspondent | Marcus Garcia VOLCANO CORPORATION 1 FORTUNE DR Billerica, MA 01821 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-27 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225010102 | K133641 | 000 |