510(k) K960081
K960081 is an FDA 510(k) premarket notification submitted by Mitsubishi Cable America, Inc. for the device "BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on March 12, 1996. The device falls under product code FCQ (Light Source, Incandescent, Diagnostic), a Class II device regulated under 21 CFR 876.1500. Mitsubishi Cable America, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1996
- Date Received
- January 11, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Source, Incandescent, Diagnostic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type