Decision Date2016-08-11
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Athena Breast Pump is a medical device manufactured by Exploramed Nc7, Inc.. It received FDA 510(k) clearance on 2016-08-11 under approval number K161266. 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 Athena Breast Pump?
Athena Breast Pump is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Exploramed Nc7, Inc.. The 510(k) number is K161266.
When was Athena Breast Pump approved by the FDA?
Athena Breast Pump received FDA 510(k) clearance on 2016-08-11, under approval number K161266.
What company makes Athena Breast Pump?
Athena Breast Pump is manufactured by Exploramed Nc7, Inc..
What is the FDA product code for Athena Breast Pump?
The FDA product code for Athena Breast Pump is HGX.
Other Devices by Exploramed Nc7, Inc.
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K160274Hi bebe plusBistos Co., Ltd.
K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven
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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.