4.5 F Lithotriptor Electrode
FDA 510(k) K830086 · Monaghan Medical Corp.
510(k) numberK830086
Submission
- Device name
- 4.5 F Lithotriptor Electrode
- Applicant
- Monaghan Medical Corp.
Walker, MI, US - Received
- January 11, 1983
- Decision date
- February 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFK – Lithotriptor, Electro-Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was 4.5 F Lithotriptor Electrode cleared by the FDA?
4.5 F Lithotriptor Electrode (K830086) received a 510(k) decision of Substantially Equivalent on February 9, 1983, 29 days after the submission was received.
What is the product code of K830086?
The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.