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FDA 510(k)

HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR

K-Number: K874605 · 1988-02-02

ApplicantMallinckrodt Critical Care
Decision Date1988-02-02
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K874605. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR?

HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K874605.

When did HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR receive FDA 510(k) clearance?

HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR received FDA 510(k) clearance on 1988-02-02, under 510(k) number K874605.

Who is the listed applicant for HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR?

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

What is the FDA product code for HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR?

The FDA product code for HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR is KRI.

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Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSORK873833THERMOCOUPLE ADAPTER

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Related Devices (Code: KRI)

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.

K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLCK992635INTERFACE MODULE IDDDStoeckert InstrumenteK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert InstrumenteK934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.K926233CARDIO2 CYCLEErgometrix, Inc.K922404TUBE GRIPGeorgia Medical Products, 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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