FDA 510(k)

Naya Breast Pump System

K-Number: K160511 · 2016-06-24

Decision Date2016-06-24

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Naya Breast Pump System is a medical device manufactured by Naya Health, Inc.. It received FDA 510(k) clearance on 2016-06-24 under approval number K160511. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Naya Breast Pump System?

Naya Breast Pump System is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Naya Health, Inc.. The 510(k) number is K160511.

When was Naya Breast Pump System approved by the FDA?

Naya Breast Pump System received FDA 510(k) clearance on 2016-06-24, under approval number K160511.

What company makes Naya Breast Pump System?

Naya Breast Pump System is manufactured by Naya Health, Inc..

What is the FDA product code for Naya Breast Pump System?

The FDA product code for Naya Breast Pump System is HGX.

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Related Devices (Code: HGX)

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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.