MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS— 510(k) K991775

Name: FDA 510(k) clearance K991775
Creator: U.S. Food and Drug Administration
Published: 1999-06-24

Substantially Equivalent

Mennen Medical, Inc.

FDA 510(k) clearance K991775 for MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS, Substantially Equivalent on 1999-06-24. Applicant: Mennen Medical, Inc.. Device class: 2.

Clearance details

Applicant: Mennen Medical, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1999-05-25
Decision date: 1999-06-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

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