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FDA 510(k)

CARDIOCAP(TM) CMO-104 MONITOR

K-Number: K882093 · 1988-07-28

Decision Date1988-07-28
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOCAP(TM) CMO-104 MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Datex Division Instrumentarium Corp.. It received FDA 510(k) clearance on 1988-07-28 under 510(k) number K882093. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOCAP(TM) CMO-104 MONITOR?

CARDIOCAP(TM) CMO-104 MONITOR is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K882093.

When did CARDIOCAP(TM) CMO-104 MONITOR receive FDA 510(k) clearance?

CARDIOCAP(TM) CMO-104 MONITOR received FDA 510(k) clearance on 1988-07-28, under 510(k) number K882093.

Who is the listed applicant for CARDIOCAP(TM) CMO-104 MONITOR?

The FDA 510(k) record lists Datex Division Instrumentarium Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOCAP(TM) CMO-104 MONITOR?

The FDA product code for CARDIOCAP(TM) CMO-104 MONITOR is DSK.

Related Clinical Trials

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.

Other records listing Datex Division Instrumentarium Corp. 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.

View all 55 devices →

Related Devices (Code: DSK)

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.

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.

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