510(k) K071793
K071793 is an FDA 510(k) premarket notification submitted by Barton Medical Corp. for the device "CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR". The FDA issued a decision of Substantially Equivalent on August 3, 2007. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 2007
- Date Received
- July 2, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Chair, Positioning, Electric
- Device Class
- Class II
- Regulation Number
- 890.3110
- Review Panel
- PM
- Submission Type