510(k) K053412
K053412 is an FDA 510(k) premarket notification submitted by Schoelly Imaging, Inc. for the device "FLEXISCOPE, MODELS 50MH AND 50 MHC". The FDA issued a decision of Substantially Equivalent on February 23, 2006. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Schoelly Imaging, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2006
- Date Received
- December 7, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Endoscopic, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type