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FDA 510(k)

Hydro-Temp Neonatal Skin Temperature Probe Cover

K-Number: K191425 · 2020-01-21

ApplicantDeroyal Industries, Inc.
Decision Date2020-01-21
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hydro-Temp Neonatal Skin Temperature Probe Cover 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 2020-01-21 under 510(k) number K191425. 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 Temperature Probe Cover?

Hydro-Temp Neonatal Skin Temperature Probe Cover is a medical device that received FDA 510(k) clearance on 2020-01-21. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K191425.

When did Hydro-Temp Neonatal Skin Temperature Probe Cover receive FDA 510(k) clearance?

Hydro-Temp Neonatal Skin Temperature Probe Cover received FDA 510(k) clearance on 2020-01-21, under 510(k) number K191425.

Who is the listed applicant for Hydro-Temp Neonatal Skin Temperature Probe Cover?

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 Temperature Probe Cover?

The FDA product code for Hydro-Temp Neonatal Skin Temperature Probe Cover is FMT.

Related Clinical Trials

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.

NCT07756892Continuous Monitoring of Body Temperature in Neonates During Therapeutic HypothermiaNOT_YET_RECRUITINGNCT04402242Impact of NOL Index Intraoperative Guided Remifentanil AnalgesiaTERMINATEDNCT07724028Neurovascular Bundle Stimulation During Robot-Assisted Radical ProstatectomyENROLLING_BY_INVITATIONNCT07732257Wireless MicroPremVitals Button Sensor in the NICURECRUITINGNCT07739823Validation of a Wireless Wearable Vital Signs Monitor in Pediatric PatientNOT_YET_RECRUITINGNCT07758205Continuous Monitoring of Body Temperature in Mothers and Their Preterm NeonatesNOT_YET_RECRUITING

Other records listing Deroyal Industries, Inc. as applicant

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.

K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryK230233Prospera Spectruum Negative Pressure Wound Therapy SystemK200631DeRoyal Temperature Monitoring ProbeK200757Foley Catheter with Temperature SensorK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableK193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French

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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 HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal 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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