PeriCoach

FDA 510(k) K143580 · Analytica, Ltd.

Substantially Equivalent

510(k) numberK143580

Submission

Device name
PeriCoach
Applicant
Analytica, Ltd.
Brisbane, AU
Received
December 18, 2014
Decision date
March 18, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HIR – Perineometer
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1425
Specialty
Obstetrics/Gynecology

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Questions and answers

When was PeriCoach cleared by the FDA?

PeriCoach (K143580) received a 510(k) decision of Substantially Equivalent on March 18, 2015, 90 days after the submission was received.

What is the product code of K143580?

The FDA product code is HIR – Perineometer, a Class II (moderate risk) device regulated under 21 CFR 884.1425.