PRO-SCOPE— 510(k) K822085

Substantially Equivalent

Exitec, Inc.

FDA 510(k) clearance K822085 for PRO-SCOPE, Substantially Equivalent on 1983-05-09. Applicant: Exitec, Inc.. Device class: 2.

Clearance details

Applicant: Exitec, Inc.
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1982-07-13
Decision date: 1983-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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