510(k) K051709
K051709 is an FDA 510(k) premarket notification submitted by Vipamat Technologie for the device "HIPPOCAMPE WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on Aug 15, 2005. The device falls under product code IQC (Wheelchair, Special Grade), a Class II device regulated under 21 CFR 890.3880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 15, 2005
- Date Received
- Jun 27, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Special Grade
- Device Class
- Class II
- Regulation Number
- 890.3880
- Review Panel
- PM
- Submission Type