FDA 510(k)

OXYMETER & TRANSOXODE

K-Number: K801858 · 1980-08-13

Decision Date1980-08-13

Product CodeKLH

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

OXYMETER & TRANSOXODE is the device name listed in this FDA 510(k) record. The listed applicant is Thoracel. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801858. The device is classified under product code KLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYMETER & TRANSOXODE?

OXYMETER & TRANSOXODE is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is Thoracel. The 510(k) number is K801858.

When did OXYMETER & TRANSOXODE receive FDA 510(k) clearance?

OXYMETER & TRANSOXODE received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801858.

Who is the listed applicant for OXYMETER & TRANSOXODE?

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

What is the FDA product code for OXYMETER & TRANSOXODE?

The FDA product code for OXYMETER & TRANSOXODE is KLH.

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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.