510(k) K001937
K001937 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE ELECTRONIC POSITIONING CHAIR". The FDA issued a decision of Substantially Equivalent on September 22, 2000. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2000
- Date Received
- June 26, 2000
- 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