SYSTEM II— 510(k) K771372

Substantially Equivalent

Irex Corp.

FDA 510(k) clearance K771372 for SYSTEM II, Substantially Equivalent on 1977-08-04. Applicant: Irex Corp.. Device class: 1.

Clearance details

Applicant: Irex Corp.
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1977-07-25
Decision date: 1977-08-04
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.