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FDA 510(k)

ORTHO-THERM INFRARED SENSOR

K-Number: K812701 · 1981-10-13

ApplicantOrthion Corp.
Decision Date1981-10-13
Product CodeIYM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ORTHO-THERM INFRARED SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthion Corp.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812701. The device is classified under product code IYM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO-THERM INFRARED SENSOR?

ORTHO-THERM INFRARED SENSOR is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Orthion Corp.. The 510(k) number is K812701.

When did ORTHO-THERM INFRARED SENSOR receive FDA 510(k) clearance?

ORTHO-THERM INFRARED SENSOR received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812701.

Who is the listed applicant for ORTHO-THERM INFRARED SENSOR?

The FDA 510(k) record lists Orthion Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO-THERM INFRARED SENSOR?

The FDA product code for ORTHO-THERM INFRARED SENSOR is IYM.

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Other records listing Orthion Corp. as applicant

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K832546MARK V HIGH VOLTAGE GALVANIC STIMULATORRK823151OB TRIPP TRANSPORT CHAIRK823149OB TILT TABLEK823105RESI-WALKERK823155LAVATORY SEAT HEIGHTENERK823154SHOWER STOOL W/HANDLES

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Related Devices (Code: IYM)

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.

K863736FMS MODEL 110Flir Medical SystemsK852950VISITHERMC.D. Regelin & Associates, Inc.K823041JEOL MODEL #JTG-500MJeolK812799DCATSDorex, Inc.K801553THERMOCOMPHospital Financial Corp.K800491GRAPHIC STRESS TELETHERMOMETRYGst Laboratories of Ca, 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.

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