510(k) K031045
K031045 is an FDA 510(k) premarket notification submitted by Economic Holland B.V. for the device "AEROLET TOILET LIFT, MODEL AER-01". The FDA issued a decision of Substantially Equivalent on July 10, 2003. 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
- July 10, 2003
- Date Received
- April 30, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Positioning, Electric
- Device Class
- Class II
- Regulation Number
- 890.3110
- Review Panel
- PM
- Submission Type