510(k) K990154

KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM by Karl Storz Imaging, Inc. — Product Code FWF

K990154 is an FDA 510(k) premarket notification submitted by Karl Storz Imaging, Inc. for the device "KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on June 1, 1999. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Karl Storz Imaging, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1999
Date Received
January 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Television, Endoscopic, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type