PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY— 510(k) K812338

Name: FDA 510(k) clearance K812338
Creator: U.S. Food and Drug Administration
Published: 1981-09-23

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K812338 for PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY, Substantially Equivalent on 1981-09-23. Applicant: Terumo Medical Corp.. Device class: 1.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code CBT
Device class: Class 1
Regulation: 21 CFR 868.1100
Advisory panel: Anesthesiology
Date received: 1981-08-18
Decision date: 1981-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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