INFUSSION ALARM SYSTEM I.A.S. CAT.#1118— 510(k) K802011

Name: FDA 510(k) clearance K802011
Creator: U.S. Food and Drug Administration
Published: 1980-10-31

Substantially Equivalent

Pollak (Intl.), Ltd.

FDA 510(k) clearance K802011 for INFUSSION ALARM SYSTEM I.A.S. CAT.#1118, Substantially Equivalent on 1980-10-31. Applicant: Pollak (Intl.), Ltd.. Device class: 2.

Clearance details

Applicant: Pollak (Intl.), Ltd.
Product code: Code FLN
Device class: Class 2
Regulation: 21 CFR 880.2420
Advisory panel: General Hospital
Date received: 1980-08-20
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.