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FDA 510(k)

NxtGen Infant Transport Incubator

K-Number: K220742 · 2022-07-15

ApplicantInternational Biomedical
Decision Date2022-07-15
Product CodeFPL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NxtGen Infant Transport Incubator is a medical device manufactured by International Biomedical. It received FDA 510(k) clearance on 2022-07-15 under approval number K220742. The device is classified under product code FPL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NxtGen Infant Transport Incubator?

NxtGen Infant Transport Incubator is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by International Biomedical. The 510(k) number is K220742.

When was NxtGen Infant Transport Incubator approved by the FDA?

NxtGen Infant Transport Incubator received FDA 510(k) clearance on 2022-07-15, under approval number K220742.

What company makes NxtGen Infant Transport Incubator?

NxtGen Infant Transport Incubator is manufactured by International Biomedical.

What is the FDA product code for NxtGen Infant Transport Incubator?

The FDA product code for NxtGen Infant Transport Incubator is FPL.

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

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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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