FDA 510(k)

OXIMETRIX ACCU SAT CPB

K-Number: K811391 · 1981-07-20

Decision Date1981-07-20

Product CodeDRY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OXIMETRIX ACCU SAT CPB is the device name listed in this FDA 510(k) record. The listed applicant is Oximetrix, Inc.. It received FDA 510(k) clearance on 1981-07-20 under 510(k) number K811391. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXIMETRIX ACCU SAT CPB?

OXIMETRIX ACCU SAT CPB is a medical device that received FDA 510(k) clearance on 1981-07-20. The listed applicant is Oximetrix, Inc.. The 510(k) number is K811391.

When did OXIMETRIX ACCU SAT CPB receive FDA 510(k) clearance?

OXIMETRIX ACCU SAT CPB received FDA 510(k) clearance on 1981-07-20, under 510(k) number K811391.

Who is the listed applicant for OXIMETRIX ACCU SAT CPB?

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

What is the FDA product code for OXIMETRIX ACCU SAT CPB?

The FDA product code for OXIMETRIX ACCU SAT CPB is DRY.

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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.