MECALL CLISIS SYSTEMS, Discovery RF180— 510(k) K173395
Substantially EquivalentGeneral Medical Merate S.P.A
FDA 510(k) clearance K173395 for MECALL CLISIS SYSTEMS, Discovery RF180, Substantially Equivalent on 2018-05-21. Applicant: General Medical Merate S.P.A. Device class: 2.
Clearance details
- Applicant
- General Medical Merate S.P.A
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Seriate, IT
Recent devices under product code JAA
view allMore clearances from General Medical Merate S.P.A
view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.