510(k) K984124

AESCULAP XENON LIGHT SOURCE by Aesculap, Inc. — Product Code FSS

K984124 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP XENON LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on February 1, 1999. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1999
Date Received
November 18, 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