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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 the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2020-04-02 under 510(k) 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. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K200319.

When did HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable receive FDA 510(k) clearance?

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 510(k) number K200319.

Who is the listed applicant for HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable?

The FDA 510(k) record lists Deroyal Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: FMT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc.K173516NuBorne Infant WarmerInternational Biomedical

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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