DOPPLER OPTION FOR PLATINUM— 510(k) K900002

Name: FDA 510(k) clearance K900002
Creator: U.S. Food and Drug Administration
Published: 1990-04-02

Substantially Equivalent

Philips Medical Systems North America, Inc.

FDA 510(k) clearance K900002 for DOPPLER OPTION FOR PLATINUM, Substantially Equivalent on 1990-04-02. Applicant: Philips Medical Systems North America, Inc.. Device class: 2.

Clearance details

Applicant: Philips Medical Systems North America, Inc.
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1990-01-02
Decision date: 1990-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.