The following data is part of a premarket notification filed by Verathon Incorporated with the FDA for Bladderscan Prime System.
| Device ID | K153101 |
| 510k Number | K153101 |
| Device Name: | BladderScan Prime System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VERATHON INCORPORATED 20001 NORTH CREEK PKWY Bothel, WA 98011 |
| Contact | Rhonda M Kops |
| 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 | 2015-10-26 |
| Decision Date | 2015-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00879123005755 | K153101 | 000 |
| 10879123005493 | K153101 | 000 |
| 10879123005165 | K153101 | 000 |
| 10879123004595 | K153101 | 000 |
| 10879123004502 | K153101 | 000 |
| 00879123004499 | K153101 | 000 |
| 10879123006490 | K153101 | 000 |
| 00879123006486 | K153101 | 000 |
| 10879123008012 | K153101 | 000 |