Uroflow-Cystometer System
FDA 510(k) K771850 · Richard Wolf Medical Instruments Corp.
510(k) numberK771850
Submission
- Device name
- Uroflow-Cystometer System
- Applicant
- Richard Wolf Medical Instruments Corp.
Mchenry, IL, US - Received
- September 29, 1977
- Decision date
- October 18, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Uroflow-Cystometer System cleared by the FDA?
Uroflow-Cystometer System (K771850) received a 510(k) decision of Substantially Equivalent on October 18, 1977, 19 days after the submission was received.
What is the product code of K771850?
The FDA product code is FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, a Class II (moderate risk) device regulated under 21 CFR 876.1620.