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FDA 510(k)

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable

K-Number: K200319 · 2020-04-02

ApplicantDeroyal Industries, Inc.
Decision Date2020-04-02
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable is a medical device manufactured by Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2020-04-02 under approval number K200319. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable?

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable is a medical device that received FDA 510(k) clearance on 2020-04-02. It is manufactured by Deroyal Industries, Inc.. The 510(k) number is K200319.

When was HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable approved by the FDA?

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable received FDA 510(k) clearance on 2020-04-02, under approval number K200319.

What company makes HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable?

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable is manufactured by Deroyal Industries, Inc..

What is the FDA product code for HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable?

The FDA product code for HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable is FMT.

Related Clinical Trials

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Related Devices (Code: FMT)

K173516NuBorne Infant WarmerInternational Biomedical K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc. K201628Panda iRes Warmer, Giraffe WarmerGE Healthcare K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. K230278Babyroo TN300Draeger Medical Systems, Inc. K243606Babyroo TN300Draeger Medical Systems, Inc.

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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