510(k) K992447
K992447 is an FDA 510(k) premarket notification submitted by Angiolaz, Inc. for the device "50 W METAL HALIDE ILLUMINATOR, VES 0501.". The FDA issued a decision of Substantially Equivalent on October 20, 1999. The device falls under product code FCW (Light Source, Fiberoptic, Routine), 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
- October 20, 1999
- Date Received
- July 22, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Source, Fiberoptic, Routine
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type