PULSIOFLEX— 510(k) K112448

Substantially Equivalent

Pulsion Medical Systems, Inc.

FDA 510(k) clearance K112448 for PULSIOFLEX, Substantially Equivalent on 2011-09-22. Applicant: Pulsion Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pulsion Medical Systems, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2011-08-25
Decision date: 2011-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Westbrook, CT, US

Download summary PDF View on FDA.gov ↗

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