VASC-ALERT— 510(k) K042566

Substantially Equivalent

Vasc-Alert, Inc.

FDA 510(k) clearance K042566 for VASC-ALERT, Substantially Equivalent on 2004-11-08. Applicant: Vasc-Alert, Inc.. Device class: 2.

Clearance details

Applicant: Vasc-Alert, Inc.
Product code: Code MQS
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2004-09-21
Decision date: 2004-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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