NEURO URODYNAMIC SUITE, MODEL 9032E0101— 510(k) K992715
Substantially EquivalentMedtronic Functional Diagnostics A/S
FDA 510(k) clearance K992715 for NEURO URODYNAMIC SUITE, MODEL 9032E0101, Substantially Equivalent on 2000-02-28. Applicant: Medtronic Functional Diagnostics A/S. Device class: 2.
Clearance details
- Applicant
- Medtronic Functional Diagnostics A/S
- Product code
- Code FEN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1620
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skovlunde, DK
Recent devices under product code FEN
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