510(k) K101563
K101563 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "SMARTO". The FDA issued a decision of Substantially Equivalent on Dec 17, 2010. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Jeil Medical Corporation has 52 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 2010
- Date Received
- Jun 4, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- OR
- Submission Type
- 510(k) Exempt