Stand Alone Cystometrogram
FDA 510(k) K934141 · Medical Engineering Corp.
510(k) numberK934141
Submission
- Device name
- Stand Alone Cystometrogram
- Applicant
- Medical Engineering Corp.
Racine, WI, US - Received
- August 25, 1993
- Decision date
- November 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FEN – Device, Cystometric, Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
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| K880802 | Surgitek Articulating Ureteroscope Model SU-11FGB · Traditional | 05/26/1988SE |
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Questions and answers
When was Stand Alone Cystometrogram cleared by the FDA?
Stand Alone Cystometrogram (K934141) received a 510(k) decision of Substantially Equivalent on November 18, 1993, 85 days after the submission was received.
What is the product code of K934141?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.