The following data is part of a premarket notification filed by Mediwatch Plc with the FDA for Portascan Bladder Scanner, Model Pa00146.
| Device ID | K033906 |
| 510k Number | K033906 |
| Device Name: | PORTASCAN BLADDER SCANNER, MODEL PA00146 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDIWATCH PLC COSFORD LANE Rugby, Warwickshire, GB Cv21 1qn |
| Contact | Andrew Hopkins |
| Correspondent | Susan Gill UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-12-17 |
| Decision Date | 2003-12-24 |