Diagnostic Ultrasound/Uro-Gyn Ups 2020, Gi Version
FDA 510(k) K920664 · Diagnostic Ultrasound Corp.
510(k) numberK920664
Submission
- Device name
- Diagnostic Ultrasound/Uro-Gyn Ups 2020, Gi Version
- Applicant
- Diagnostic Ultrasound Corp.
Kirkland, WA, US - Received
- February 13, 1992
- Decision date
- December 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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| K982568 | Bladdermanager Pci 5000 Model 1002ITX · Traditional | 01/25/1999SE |
| K963585 | Bladder Manager Pci 5000, Bladderscan Bvi 5000IYO · Traditional | 10/01/1996SE |
| K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000IYO · Traditional | 05/24/1996SE |
| K955942 | Bladderscan Bvi 5000IYO · Traditional | 03/15/1996SE |
| K915342 | Ud 2000 Video OptionLLZ · Traditional | 06/10/1992SE |
| K915436 | Bladderscan Bvi 2500IYO · Traditional | 03/03/1992SE |
| K911166 | Diagnostic Ultrasound/Uro-Gyn Ud 511DXT · Traditional | 08/15/1991SE |
| K911125 | Diagnostic Ultrasound/Uro-Gyn Ups 2020FAP · Traditional | 08/15/1991SE |
Questions and answers
When was Diagnostic Ultrasound/Uro-Gyn Ups 2020, Gi Version cleared by the FDA?
Diagnostic Ultrasound/Uro-Gyn Ups 2020, Gi Version (K920664) received a 510(k) decision of Substantially Equivalent on December 23, 1993, 679 days after the submission was received.
What is the product code of K920664?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.