510(k) K855151
K855151 is an FDA 510(k) premarket notification submitted by Regtec for the device "FRITCH OPHTHALMIC ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on February 19, 1986. The device falls under product code GDB (Endoscope, Fiber Optic), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1986
- Date Received
- December 26, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Fiber Optic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type