510(k) K142984
K142984 is an FDA 510(k) premarket notification submitted by Sunnex, Inc. for the device "Leo Minor". The FDA issued a decision of Substantially Equivalent on October 29, 2014. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Sunnex, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2014
- Date Received
- October 16, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Light, Surgical, Ceiling Mounted
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type