510(k) K131893
K131893 is an FDA 510(k) premarket notification submitted by Ajw Technology Consultants, Inc. for the device "AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS". The FDA issued a decision of Substantially Equivalent on October 30, 2013. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Ajw Technology Consultants, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2013
- Date Received
- June 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Ceiling Mounted
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type