HORIZON 9000/HIS OPTION AMPLIFIER— 510(k) K914381

Name: FDA 510(k) clearance K914381
Creator: U.S. Food and Drug Administration
Published: 1992-01-28

Substantially Equivalent

Mennen Medical, Inc.

FDA 510(k) clearance K914381 for HORIZON 9000/HIS OPTION AMPLIFIER, Substantially Equivalent on 1992-01-28. Applicant: Mennen Medical, Inc.. Device class: 2.

Clearance details

Applicant: Mennen Medical, Inc.
Product code: Code DRR
Device class: Class 2
Regulation: 21 CFR 870.2050
Advisory panel: Cardiovascular
Date received: 1991-10-03
Decision date: 1992-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

Download summary PDF View on FDA.gov ↗

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