510(k) K981821

VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR by Angiolaz, Inc. — Product Code FSS

K981821 is an FDA 510(k) premarket notification submitted by Angiolaz, Inc. for the device "VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on July 29, 1998. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Angiolaz, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1998
Date Received
May 22, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Floor Standing
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type