ORGANON ARTERIAL BLOOD SAMPLER— 510(k) K801435

Substantially Equivalent

Akzona, Inc.

FDA 510(k) clearance K801435 for ORGANON ARTERIAL BLOOD SAMPLER, Substantially Equivalent on 1980-07-18. Applicant: Akzona, Inc.. Device class: 1.

Clearance details

Applicant: Akzona, Inc.
Product code: Code CBT
Device class: Class 1
Regulation: 21 CFR 868.1100
Advisory panel: Anesthesiology
Date received: 1980-06-19
Decision date: 1980-07-18
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.