KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM

Camera, Television, Endoscopic, Without Audio

KARL STORZ IMAGING, INC.

The following data is part of a premarket notification filed by Karl Storz Imaging, Inc. with the FDA for Karl Storz Direct Coupled Interface (dci 5) Camera System.

Pre-market Notification Details

• Device ID: K990154
• 510k Number: K990154
• Device Name: KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
• Classification: Camera, Television, Endoscopic, Without Audio
• Applicant: KARL STORZ IMAGING, INC. 175 CREMONA DR. Goleta, CA 93117
• Contact: Terry Fernandez
• Correspondent: Terry Fernandez; KARL STORZ IMAGING, INC. 175 CREMONA DR. Goleta, CA 93117
• Product Code: FWF
• CFR Regulation Number: 878.4160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-01-19
• Decision Date: 1999-06-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551064320	K990154	000
04048551064313	K990154	000