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FDA 510(k)

OMNI THERM TEMPERATURE MONITOR

K-Number: K864853 · 1987-02-04

ApplicantOmni Therm, Inc.
Decision Date1987-02-04
Product CodeKPD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OMNI THERM TEMPERATURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Omni Therm, Inc.. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K864853. The device is classified under product code KPD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI THERM TEMPERATURE MONITOR?

OMNI THERM TEMPERATURE MONITOR is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Omni Therm, Inc.. The 510(k) number is K864853.

When did OMNI THERM TEMPERATURE MONITOR receive FDA 510(k) clearance?

OMNI THERM TEMPERATURE MONITOR received FDA 510(k) clearance on 1987-02-04, under 510(k) number K864853.

Who is the listed applicant for OMNI THERM TEMPERATURE MONITOR?

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

What is the FDA product code for OMNI THERM TEMPERATURE MONITOR?

The FDA product code for OMNI THERM TEMPERATURE MONITOR is KPD.

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.

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Other records listing Omni Therm, 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.

K961176OMNI COLD GEL PACKSK955788IMNI HOT PACKSK954877OMNI COLD GEL PACKSK936084OMNI WARM GEL PACKS

Related Devices (Code: KPD)

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.

K934941E-Z TEMP IISeven C'S, Inc.K903307TEMP MARQ TEMPERATURE TREND INDICATORMarquest Medical Products, Inc.K893803FEVER LINE AND FEVER LINE PLUSLiquid Crystal Sciences, Inc.K850797TEMPALERT LIQUID CRYSTAL THERMOMETERMedical Frontiers, Inc.K841913TEMPTREND PEDS AXILLARY TEMP. INDICATORBiosynergy, Inc.K833904TEMPTREND IIBiosynergy, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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