510(k) K211001
K211001 is an FDA 510(k) premarket notification submitted by Medtec, Inc. Dba Civco Medical Solutions And Civco for the device "C-Qual M Breastboard; Monarch Overhead Arm Positioner". The FDA issued a decision of Substantially Equivalent on May 20, 2021. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2021
- Date Received
- Apr 2, 2021
- 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
- 510(k)