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FDA 510(k)

DATASCOPE PASSPORT MONITOR WITH CO2

K-Number: K921526 · 1992-10-14

ApplicantDatascope Corp.
Decision Date1992-10-14
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DATASCOPE PASSPORT MONITOR WITH CO2 is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1992-10-14 under 510(k) number K921526. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATASCOPE PASSPORT MONITOR WITH CO2?

DATASCOPE PASSPORT MONITOR WITH CO2 is a medical device that received FDA 510(k) clearance on 1992-10-14. The listed applicant is Datascope Corp.. The 510(k) number is K921526.

When did DATASCOPE PASSPORT MONITOR WITH CO2 receive FDA 510(k) clearance?

DATASCOPE PASSPORT MONITOR WITH CO2 received FDA 510(k) clearance on 1992-10-14, under 510(k) number K921526.

Who is the listed applicant for DATASCOPE PASSPORT MONITOR WITH CO2?

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

What is the FDA product code for DATASCOPE PASSPORT MONITOR WITH CO2?

The FDA product code for DATASCOPE PASSPORT MONITOR WITH CO2 is CCK.

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Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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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