FDA 510(k)

AS/3 CARDIAC OUTPUT & SVO2 MODULE

K-Number: K961063 · 1996-05-31

ApplicantDatex Medical Instrumentation, Inc.

Decision Date1996-05-31

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AS/3 CARDIAC OUTPUT & SVO2 MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Datex Medical Instrumentation, Inc.. It received FDA 510(k) clearance on 1996-05-31 under 510(k) number K961063. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AS/3 CARDIAC OUTPUT & SVO2 MODULE?

AS/3 CARDIAC OUTPUT & SVO2 MODULE is a medical device that received FDA 510(k) clearance on 1996-05-31. The listed applicant is Datex Medical Instrumentation, Inc.. The 510(k) number is K961063.

When did AS/3 CARDIAC OUTPUT & SVO2 MODULE receive FDA 510(k) clearance?

AS/3 CARDIAC OUTPUT & SVO2 MODULE received FDA 510(k) clearance on 1996-05-31, under 510(k) number K961063.

Who is the listed applicant for AS/3 CARDIAC OUTPUT & SVO2 MODULE?

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

What is the FDA product code for AS/3 CARDIAC OUTPUT & SVO2 MODULE?

The FDA product code for AS/3 CARDIAC OUTPUT & SVO2 MODULE is DQK.

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Other records listing Datex Medical Instrumentation, Inc. as applicant

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Related Devices (Code: DQK)

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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.