PULSTAR LOGIX PUMP— 510(k) K141609

Substantially Equivalent

Albahealth, LLC

FDA 510(k) clearance K141609 for PULSTAR LOGIX PUMP, Substantially Equivalent on 2014-07-15. Applicant: Albahealth, LLC. Device class: 2.

Clearance details

Applicant: Albahealth, LLC
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2014-06-16
Decision date: 2014-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Rockwood, TN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.