Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO

K-Number: K925006 · 1994-01-31

ApplicantDeroyal Industries, Inc.
Decision Date1994-01-31
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO 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 1994-01-31 under 510(k) number K925006. 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 NICU AND SKIN SURFACE TEMPERATURE SENSO?

HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO is a medical device that received FDA 510(k) clearance on 1994-01-31. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K925006.

When did HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO receive FDA 510(k) clearance?

HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO received FDA 510(k) clearance on 1994-01-31, under 510(k) number K925006.

Who is the listed applicant for HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO?

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 NICU AND SKIN SURFACE TEMPERATURE SENSO?

The FDA product code for HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_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

View all 90 devices →

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.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, 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.

↑