510(k) K933868
K933868 is an FDA 510(k) premarket notification submitted by Angiolaz, Inc. for the device "ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on November 10, 1993. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Angiolaz, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 1993
- Date Received
- August 6, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Source, Endoscope, Xenon Arc
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type