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FDA 510(k)

TEMPO2-II DISPOSABLE THERMOMETERS

K-Number: K790891 · 1979-06-27

ApplicantAirlife, Inc.
Decision Date1979-06-27
Product CodeFLK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMPO2-II DISPOSABLE THERMOMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1979-06-27 under 510(k) number K790891. The device is classified under product code FLK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPO2-II DISPOSABLE THERMOMETERS?

TEMPO2-II DISPOSABLE THERMOMETERS is a medical device that received FDA 510(k) clearance on 1979-06-27. The listed applicant is Airlife, Inc.. The 510(k) number is K790891.

When did TEMPO2-II DISPOSABLE THERMOMETERS receive FDA 510(k) clearance?

TEMPO2-II DISPOSABLE THERMOMETERS received FDA 510(k) clearance on 1979-06-27, under 510(k) number K790891.

Who is the listed applicant for TEMPO2-II DISPOSABLE THERMOMETERS?

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

What is the FDA product code for TEMPO2-II DISPOSABLE THERMOMETERS?

The FDA product code for TEMPO2-II DISPOSABLE THERMOMETERS is FLK.

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Other records listing Airlife, Inc. as applicant

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K834573AQUA TRAPK834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPK834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAINK833196VOLUME VENTILATOR CIRCUIT-NEBULIZERK833197TRACH SWIVE/CONNECTORK832725DUAL DIAL VENTURI STYLE MASK

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Related Devices (Code: FLK)

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.

K960185AMSINO CLINICAL THERMOMETERAmsia Intl., Inc.K960224GERATHERM MERCUIRY FREE CLINICAL THERMOMETERRg Ent., Inc.K953465KENTEMPKentron Health Care, Inc.K942483CLINICAL GLASS THERMOMETERMakol Medical Instruments Corp.K941673MEDIAID UNIVERSAL THERMOMETERPolymedica Industries, Inc.K940394AMG MED BRAND CLINICAL GLASS THERMOMETERTechnolab Industries (Canada) , 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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