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FDA 510(k)

EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S

K-Number: K925790 · 1993-05-17

ApplicantDeroyal Industries, Inc.
Decision Date1993-05-17
Product CodeEYC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S 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 1993-05-17 under 510(k) number K925790. The device is classified under product code EYC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S?

EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S is a medical device that received FDA 510(k) clearance on 1993-05-17. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K925790.

When did EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S receive FDA 510(k) clearance?

EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S received FDA 510(k) clearance on 1993-05-17, under 510(k) number K925790.

Who is the listed applicant for EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S?

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 EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S?

The FDA product code for EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S is EYC.

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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: EYC)

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.

K200757Foley Catheter with Temperature SensorDeroyal Industries, Inc.K061918FOLEY CATHETERS WITH TEMPERATURE PROBEGE HealthcareK041416EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETERDeroyalK890310STERILE FOLEY CATHETERKosan Far East Ent. , Ltd.

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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