EXPLOR-X 70— 510(k) K991310
Substantially EquivalentVilla Sistemi Medicali S.P.A.
FDA 510(k) clearance K991310 for EXPLOR-X 70, Substantially Equivalent on 1999-06-18. Applicant: Villa Sistemi Medicali S.P.A.. Device class: 2.
Clearance details
- Applicant
- Villa Sistemi Medicali S.P.A.
- Product code
- Code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheeling, IL, US
Recent devices under product code EHD
view allMore clearances from Villa Sistemi Medicali S.P.A.
view all- K180601 — Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
- K162190 — Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
- K130109 — ENDOGRAPH DC
- K111152 — ROTOGRAPH EVO 3D
- K090749 — ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
Data sourced from openFDA. This site is unofficial and independent of the FDA.