FDA 510(k)

PeriCoach OTC

K-Number: K160758 · 2016-07-11

Decision Date2016-07-11

Product CodeHIR

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PeriCoach OTC is the device name listed in this FDA 510(k) record. The listed applicant is Analytica, Ltd.. It received FDA 510(k) clearance on 2016-07-11 under 510(k) 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. The listed applicant is Analytica, Ltd.. The 510(k) number is K160758.

When did PeriCoach OTC receive FDA 510(k) clearance?

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

Who is the listed applicant for PeriCoach OTC?

The FDA 510(k) record lists Analytica, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PeriCoach OTC?

The FDA product code for PeriCoach OTC is HIR.

Related Devices (Code: HIR)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.