The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Intrasight Mobile.
| Device ID | K203719 |
| 510k Number | K203719 |
| Device Name: | IntraSight Mobile |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Contact | Linda Schulz |
| Correspondent | Linda Schulz Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Product Code | IYO |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSK |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2021-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225012915 | K203719 | 000 |