The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Bladderscan Bvi 6100.
| Device ID | K022153 |
| 510k Number | K022153 |
| Device Name: | BLADDERSCAN BVI 6100 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DIAGNOSTIC ULTRASOUND CORP. 21222 30TH DRIVE SE, STE. 120 Bothell, WA 98021 |
| Contact | Russ Garrison |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2002-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10879123006179 | K022153 | 000 |
| 00879123001641 | K022153 | 000 |
| 10879123001969 | K022153 | 000 |
| 00879123002518 | K022153 | 000 |
| 10879123002522 | K022153 | 000 |
| 00879123004239 | K022153 | 000 |
| 00879123005564 | K022153 | 000 |
| 00879123005571 | K022153 | 000 |
| 00879123006127 | K022153 | 000 |
| 00879123006134 | K022153 | 000 |
| 00879123006141 | K022153 | 000 |
| 00879123001634 | K022153 | 000 |