GALILEO ENDOSCOPES— 510(k) K934649
Substantially EquivalentGalileo Electro-Optics Corp.
FDA 510(k) clearance K934649 for GALILEO ENDOSCOPES, Substantially Equivalent on 1994-10-13. Applicant: Galileo Electro-Optics Corp.. Device class: 2.
Clearance details
- Applicant
- Galileo Electro-Optics Corp.
- Product code
- Code FBO
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sturbridge, MA, US
Recent devices under product code FBO
view all- K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
- K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
- K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
- K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
- K080780 — ANCHORAGE SCOPE, MODEL 000003
More clearances from Galileo Electro-Optics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.