510(k) K940590
K940590 is an FDA 510(k) premarket notification submitted by Minto Research & Development, Inc. for the device "MINTO SKIN TRACTION MOTOR". The FDA issued a decision of Substantially Equivalent on April 15, 1994. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Minto Research & Development, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 1994
- Date Received
- February 8, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type