Cleared Traditional

NxtGen Infant Transport Incubator

K220742 · International Biomedical · General Hospital
Jul 2022
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K220742 is an FDA 510(k) clearance for the NxtGen Infant Transport Incubator, a Incubator, Neonatal Transport (Class II — Special Controls, product code FPL), submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on July 15, 2022, 123 days after receiving the submission on March 14, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5410.

Submission Details

510(k) Number K220742 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2022
Decision Date July 15, 2022
Days to Decision 123 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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