CRITIVIEW, MODEL CRV3— 510(k) K062977

Substantially Equivalent

Critisense , Ltd.

FDA 510(k) clearance K062977 for CRITIVIEW, MODEL CRV3, Substantially Equivalent on 2007-02-28. Applicant: Critisense , Ltd.. Device class: 2.

Clearance details

Applicant: Critisense , Ltd.
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2006-09-29
Decision date: 2007-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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