510(k) K013242
K013242 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 2001. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. STERIS Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2001
- Date Received
- September 28, 2001
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type