TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA— 510(k) K884122

Name: FDA 510(k) clearance K884122
Creator: U.S. Food and Drug Administration
Published: 1989-04-25

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K884122 for TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA, Substantially Equivalent on 1989-04-25. Applicant: S & W Medico Teknik. Device class: 2.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1988-09-30
Decision date: 1989-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

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