FLUID WARMER— 510(k) K842302

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K842302 for FLUID WARMER, Substantially Equivalent on 1984-08-27. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code FLA
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1984-06-11
Decision date: 1984-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Organon Teknika Corp.

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K993423 — BACT/ALERT SA1999-12-15

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