510(k) K113357
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2012
- Date Received
- November 14, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Patient Bed With Canopy/Restraints
- Device Class
- Class I
- Regulation Number
- 880.6760
- Review Panel
- HO
- Submission Type
Enclosed bed canopy system used as passive restraint.