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FDA 510(k)

THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER

K-Number: K901281 · 1991-08-28

ApplicantVal-Mark Medical, Inc.
Decision Date1991-08-28
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Val-Mark Medical, Inc.. It received FDA 510(k) clearance on 1991-08-28 under 510(k) number K901281. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER?

THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Val-Mark Medical, Inc.. The 510(k) number is K901281.

When did THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER receive FDA 510(k) clearance?

THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER received FDA 510(k) clearance on 1991-08-28, under 510(k) number K901281.

Who is the listed applicant for THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER?

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

What is the FDA product code for THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER?

The FDA product code for THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER is DRB.

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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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