Cleared Traditional

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

K162165 · Summit Medical Products, Inc. · General Hospital
Aug 2017
Decision
391d
Days
Class 2
Risk

About This 510(k) Submission

K162165 is an FDA 510(k) clearance for the ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump, a Pump, Infusion, Pca (Class II — Special Controls, product code MEA), submitted by Summit Medical Products, Inc. (Sandy, US). The FDA issued a Cleared decision on August 29, 2017, 391 days after receiving the submission on August 3, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K162165 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2016
Decision Date August 29, 2017
Days to Decision 391 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEA — Pump, Infusion, Pca
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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