MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR— 510(k) K083029
Substantially EquivalentRalco S.R.L.
FDA 510(k) clearance K083029 for MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR, Substantially Equivalent on 2008-12-05. Applicant: Ralco S.R.L.. Device class: 2.
Clearance details
- Applicant
- Ralco S.R.L.
- Product code
- Code IZW
- Device class
- Class 2
- Regulation
- 21 CFR 892.1610
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deer Field, IL, US
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