FDA 510(k)

EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR

K-Number: K843955 · 1984-11-29

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1984-11-29

Product CodeDTZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1984-11-29 under 510(k) number K843955. 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 EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR?

EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR is a medical device that received FDA 510(k) clearance on 1984-11-29. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K843955.

When did EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR receive FDA 510(k) clearance?

EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR received FDA 510(k) clearance on 1984-11-29, under 510(k) number K843955.

Who is the listed applicant for EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR?

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

What is the FDA product code for EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR?

The FDA product code for EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR 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.