Atlas FDA

KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS

FDA 510(k) clearance K950974 · decided 1995-05-11

Clearance details

K-number
K950974
Device name
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS
Applicant
Karl Storz Imaging, Inc.
Decision
Substantially Equivalent
Date received
1995-03-02
Decision date
1995-05-11
Days to decision
70 days
Clearance type
Traditional
Product code
FET
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Goleta, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.