SKYLARK URO PROBE— 510(k) K053007
Substantially EquivalentSkylark Device & Systems Co., Ltd.
FDA 510(k) clearance K053007 for SKYLARK URO PROBE, Substantially Equivalent on 2005-12-05. Applicant: Skylark Device & Systems Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Skylark Device & Systems Co., Ltd.
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, TW
Recent devices under product code KPI
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- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
More clearances from Skylark Device & Systems Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.