RFA-1717DIG, RFA-1717DIC— 510(k) K212051
Substantially EquivalentAstel, Inc.
FDA 510(k) clearance K212051 for RFA-1717DIG, RFA-1717DIC, Substantially Equivalent on 2021-08-25. Applicant: Astel, Inc.. Device class: 2.
Clearance details
- Applicant
- Astel, Inc.
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Daejeon, KR
Recent devices under product code MQB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.