TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM— 510(k) K031786

Substantially Equivalent

Vision-Sciences, Inc.

FDA 510(k) clearance K031786 for TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM, Substantially Equivalent on 2003-08-05. Applicant: Vision-Sciences, Inc.. Device class: 2.

Clearance details

Applicant
Vision-Sciences, Inc.
Product code
Code EOX
Device class
Class 2
Regulation
21 CFR 874.4710
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ayer, MA, US
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