MODEL BION 1/TYPE 1084T CAR IONIZER— 510(k) K851094

Name: FDA 510(k) clearance K851094
Creator: U.S. Food and Drug Administration
Published: 1985-06-19

Substantially Equivalent

Medicor USA , Ltd.

FDA 510(k) clearance K851094 for MODEL BION 1/TYPE 1084T CAR IONIZER, Substantially Equivalent on 1985-06-19. Applicant: Medicor USA , Ltd.. Device class: 2.

Clearance details

Applicant: Medicor USA , Ltd.
Product code: Code FRF
Device class: Class 2
Regulation: 21 CFR 880.5045
Advisory panel: General Hospital
Date received: 1985-03-19
Decision date: 1985-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

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