The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Diagnostic Ultrasound/uro-gyn Ups 2020.
| Device ID | K911125 |
| 510k Number | K911125 |
| Device Name: | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | DIAGNOSTIC ULTRASOUND CORP. P.O. BOX 0789 Kirkland, WA 98083 -0789 |
| Contact | Gerald Mcmorrow |
| Correspondent | Gerald Mcmorrow DIAGNOSTIC ULTRASOUND CORP. P.O. BOX 0789 Kirkland, WA 98083 -0789 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-13 |
| Decision Date | 1991-08-15 |