PERITRON PERINEOMETER MODEL 9300V OR 9300A— 510(k) K983052

Name: FDA 510(k) clearance K983052
Creator: U.S. Food and Drug Administration
Published: 1998-10-19

Substantially Equivalent

Cardio Design Pty. , Ltd.

FDA 510(k) clearance K983052 for PERITRON PERINEOMETER MODEL 9300V OR 9300A, Substantially Equivalent on 1998-10-19. 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: 1998-09-01
Decision date: 1998-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baulkham Hills Nsw, AU

Download summary PDF View on FDA.gov ↗

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