Cleared Traditional

AG MASS

K131099 · Hospitech Respiration , Ltd. · General & Plastic Surgery
May 2013
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K131099 is an FDA 510(k) clearance for the AG MASS, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Hospitech Respiration , Ltd. (Binyamina, IL). The FDA issued a Cleared decision on May 13, 2013, 24 days after receiving the submission on April 19, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K131099 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2013
Decision Date May 13, 2013
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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