FE-24X, FIBER ESOPHAGOSCOPE— 510(k) K951197

Name: FDA 510(k) clearance K951197
Creator: U.S. Food and Drug Administration
Published: 1995-05-30

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K951197 for FE-24X, FIBER ESOPHAGOSCOPE, Substantially Equivalent on 1995-05-30. Applicant: Pentax Precision Instrument Corp.. Device class: 2.

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code GCL
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1995-03-16
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

Download summary PDF View on FDA.gov ↗

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