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FDA 510(k)

TRANSCUTANEOUS OXYGEN MONITOR

K-Number: K800073 · 1980-02-05

ApplicantBiochem International, Inc.
Decision Date1980-02-05
Product Code
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Biochem International, Inc.. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K800073. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSCUTANEOUS OXYGEN MONITOR?

TRANSCUTANEOUS OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Biochem International, Inc.. The 510(k) number is K800073.

When did TRANSCUTANEOUS OXYGEN MONITOR receive FDA 510(k) clearance?

TRANSCUTANEOUS OXYGEN MONITOR received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800073.

Who is the listed applicant for TRANSCUTANEOUS OXYGEN MONITOR?

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

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Other records listing Biochem International, Inc. 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.

K920083BIOCHEM MODEL 3302 NEWOX2 OXIMETERK9323898100 ANESTHETIC AGENT MONITORK921388BIOCHEM 9100 MULTIGAS MONITOR IBP MODULEK920082BIOCHEM MODEL 3301 NEWOX1 OXIMETERK910381BIOCHEM TEMPERATURE/ FIO2 MODULEK911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP

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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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