510(k) K023521
K023521 is an FDA 510(k) premarket notification submitted by Berkline Corp. for the device "EASY LIFE". The FDA issued a decision of Substantially Equivalent on November 19, 2002. 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
- November 19, 2002
- Date Received
- October 21, 2002
- 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