MODIFICATION TO RESQPOD CIRCULATORY ENHANCER— 510(k) K033401

Substantially Equivalent

Advanced Circulatory Systems, Inc.

FDA 510(k) clearance K033401 for MODIFICATION TO RESQPOD CIRCULATORY ENHANCER, Substantially Equivalent on 2003-11-20. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Stoughton, WI, US
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