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FDA 510(k)

PeriCoach OTC

K-Number: K160758 · 2016-07-11

ApplicantAnalytica, Ltd.
Decision Date2016-07-11
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PeriCoach OTC is a medical device manufactured by Analytica, Ltd.. It received FDA 510(k) clearance on 2016-07-11 under approval number K160758. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PeriCoach OTC?

PeriCoach OTC is a medical device that received FDA 510(k) clearance on 2016-07-11. It is manufactured by Analytica, Ltd.. The 510(k) number is K160758.

When was PeriCoach OTC approved by the FDA?

PeriCoach OTC received FDA 510(k) clearance on 2016-07-11, under approval number K160758.

What company makes PeriCoach OTC?

PeriCoach OTC is manufactured by Analytica, Ltd..

What is the FDA product code for PeriCoach OTC?

The FDA product code for PeriCoach OTC is HIR.

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Official Source

View on FDA Database →

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