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FDA 510(k)

TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I

K-Number: K760824 · 1976-11-12

ApplicantTravenol Laboratories, S.A.
Decision Date1976-11-12
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1976-11-12 under 510(k) number K760824. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I?

TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I is a medical device that received FDA 510(k) clearance on 1976-11-12. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K760824.

When did TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I receive FDA 510(k) clearance?

TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I received FDA 510(k) clearance on 1976-11-12, under 510(k) number K760824.

Who is the listed applicant for TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I?

The FDA product code for TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I is DTZ.

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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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