Laborie Urodynamic System with Tetra Accessory
FDA 510(k) K073552 · Laborie Medical Technologies, Corp.
510(k) numberK073552
Submission
- Device name
- Laborie Urodynamic System with Tetra Accessory
- Applicant
- Laborie Medical Technologies, Corp.
Williston, VT, US - Received
- December 18, 2007
- Decision date
- March 5, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K070331 | Urostym Biofeedback and Stimulation Device and AccessoriesKPI · Traditional | 05/04/2007SE |
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Questions and answers
When was Laborie Urodynamic System with Tetra Accessory cleared by the FDA?
Laborie Urodynamic System with Tetra Accessory (K073552) received a 510(k) decision of Substantially Equivalent on March 5, 2008, 78 days after the submission was received.
What is the product code of K073552?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.