CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)— 510(k) K070490

Name: FDA 510(k) clearance K070490
Creator: U.S. Food and Drug Administration
Published: 2007-06-20

Substantially Equivalent

Advanced Circulatory Systems, Inc.

FDA 510(k) clearance K070490 for CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR), Substantially Equivalent on 2007-06-20. Applicant: Advanced Circulatory Systems, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Circulatory Systems, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2007-02-20
Decision date: 2007-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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