Cleared Traditional

ATOM TRANSCAPSULE V-707

K123937 · Atom Medical Corporation · General Hospital
May 2013
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K123937 is an FDA 510(k) clearance for the ATOM TRANSCAPSULE V-707, a Incubator, Neonatal Transport (Class II — Special Controls, product code FPL), submitted by Atom Medical Corporation (Bonita Springs, US). The FDA issued a Cleared decision on May 23, 2013, 154 days after receiving the submission on December 20, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5410.

Submission Details

510(k) Number K123937 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2012
Decision Date May 23, 2013
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPL — Incubator, Neonatal Transport
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5410

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