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FDA 510(k)

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

K-Number: K162165 · 2017-08-29

ApplicantSummit Medical Products, Inc.
Decision Date2017-08-29
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump is a medical device manufactured by Summit Medical Products, Inc.. It received FDA 510(k) clearance on 2017-08-29 under approval number K162165. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump?

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump is a medical device that received FDA 510(k) clearance on 2017-08-29. It is manufactured by Summit Medical Products, Inc.. The 510(k) number is K162165.

When was ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump approved by the FDA?

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump received FDA 510(k) clearance on 2017-08-29, under approval number K162165.

What company makes ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump?

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump is manufactured by Summit Medical Products, Inc..

What is the FDA product code for ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump?

The FDA product code for ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump is MEA.

Related Devices (Code: MEA)

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Official Source

View on FDA Database →

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

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