510(k) K142420
K142420 is an FDA 510(k) premarket notification submitted by Macromedics BV for the device "Patient Positioning Devices". The FDA issued a decision of Substantially Equivalent on Mar 27, 2015. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Macromedics BV has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 27, 2015
- Date Received
- Aug 28, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type