CINE/VIEW PLUS - CARDIOLOGY WORKSTATION— 510(k) K904977

Name: FDA 510(k) clearance K904977
Creator: U.S. Food and Drug Administration
Published: 1991-02-25

Substantially Equivalent

Prism Imaging, Inc.

FDA 510(k) clearance K904977 for CINE/VIEW PLUS - CARDIOLOGY WORKSTATION, Substantially Equivalent on 1991-02-25. Applicant: Prism Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Prism Imaging, Inc.
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1990-11-01
Decision date: 1991-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Prism Imaging, Inc.

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K904975 — VISTA VIEWING STATION1991-02-25
K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEW1991-02-25
K904978 — SOFTWARE PROGRAM USED W/PRISM PRODUCTS1991-02-25

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