The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano Lomap,volcano Lomap Option Kit For Mobile System,volcano Lomap Option For Integrated System,volcano S5 Precision.
| Device ID | K133142 |
| 510k Number | K133142 |
| Device Name: | VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO CORPORATION 1 FORTUNE DR Billerica, MA 01821 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan 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 | 2013-10-17 |
| Decision Date | 2013-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225001261 | K133142 | 000 |