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FDA 510(k)

OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR

K-Number: K850622 · 1985-04-10

ApplicantOscor Medical Corp.
Decision Date1985-04-10
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR is the device name listed in this FDA 510(k) record. The listed applicant is Oscor Medical Corp.. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K850622. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR?

OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Oscor Medical Corp.. The 510(k) number is K850622.

When did OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR receive FDA 510(k) clearance?

OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR received FDA 510(k) clearance on 1985-04-10, under 510(k) number K850622.

Who is the listed applicant for OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR?

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

What is the FDA product code for OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR?

The FDA product code for OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR is LDF.

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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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