The following data is part of a premarket notification filed by Verathon Incorporated with the FDA for Bladderscan Prime Plus System.
| Device ID | K172356 |
| 510k Number | K172356 |
| Device Name: | BladderScan Prime PLUS System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Verathon Incorporated 20001 North Creek Parkway Bothell, WA 98011 |
| Contact | Swapna Chirala |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-08-03 |
| Decision Date | 2017-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10879123008234 | K172356 | 000 |
| 10879123008142 | K172356 | 000 |
| 00879123007896 | K172356 | 000 |
| 00879123007452 | K172356 | 000 |
| 00879123007445 | K172356 | 000 |
| 00879123007438 | K172356 | 000 |
| 10879123007411 | K172356 | 000 |
| 00879123001511 | K172356 | 000 |