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510(k) K944707

ISOLATED CAMERA HEAD by Envision Medical Corp. — Product Code FWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1994
Date Received
September 23, 1994
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

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  • K934092 — CAMERA, SURGICAL AND ACCESSORIES (January 7, 1994)

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  • K981819 — ANGIOLAZ VES-1CAM (August 4, 1998)
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  • K934682 — SURGICAL VIDEO CAMERA AND ACCESSORIES (February 15, 1994)
  • K932628 — ENDOSCOPIC VIDEO CAMERA (October 15, 1993)