ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1— 510(k) K010482

Name: FDA 510(k) clearance K010482
Creator: U.S. Food and Drug Administration
Published: 2001-03-20

Substantially Equivalent

Echocath, Inc.

FDA 510(k) clearance K010482 for ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1, Substantially Equivalent on 2001-03-20. Applicant: Echocath, Inc.. Device class: 2.

Clearance details

Applicant: Echocath, Inc.
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 2001-02-20
Decision date: 2001-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Monmouth Junction, NJ, US

Download summary PDF View on FDA.gov ↗

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