PERITRON— 510(k) K945611

Substantially Equivalent

Cardio Design Pty. , Ltd.

FDA 510(k) clearance K945611 for PERITRON, Substantially Equivalent on 1996-02-08. Applicant: Cardio Design Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Cardio Design Pty. , Ltd.
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 1994-11-15
Decision date: 1996-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, 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.