ROCHE AXISCAN 5— 510(k) K771816

Name: FDA 510(k) clearance K771816
Creator: U.S. Food and Drug Administration
Published: 1977-10-19

Substantially Equivalent

Roche Medical Electronics, Inc.

FDA 510(k) clearance K771816 for ROCHE AXISCAN 5, Substantially Equivalent on 1977-10-19. Applicant: Roche Medical Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Roche Medical Electronics, Inc.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1977-09-27
Decision date: 1977-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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