510(k) K083029
K083029 is an FDA 510(k) premarket notification submitted by Ralco S.R.L. for the device "MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR". The FDA issued a decision of Substantially Equivalent on Dec 5, 2008. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Ralco S.R.L. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 5, 2008
- Date Received
- Oct 10, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, Automatic, Radiographic
- Device Class
- Class II
- Regulation Number
- 892.1610
- Review Panel
- RA
- Submission Type
- 510(k) Exempt