CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP— 510(k) K970595
Substantially EquivalentCircon Video
FDA 510(k) clearance K970595 for CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP, Substantially Equivalent on 1997-10-24. Applicant: Circon Video. Device class: 2.
Clearance details
- Applicant
- Circon Video
- 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
- Santa Barbara, CA, US
Recent devices under product code FEN
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view all- K012758 — URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
- K011876 — DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
- K011849 — MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
- K012929 — FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
- K012951 — APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
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