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FDA 510(k)

TRIO MONITOR MODEL 0998-00-0600

K-Number: K032338 · 2004-02-11

ApplicantDatascope Corp.
Decision Date2004-02-11
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRIO MONITOR MODEL 0998-00-0600 is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2004-02-11 under 510(k) number K032338. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIO MONITOR MODEL 0998-00-0600?

TRIO MONITOR MODEL 0998-00-0600 is a medical device that received FDA 510(k) clearance on 2004-02-11. The listed applicant is Datascope Corp.. The 510(k) number is K032338.

When did TRIO MONITOR MODEL 0998-00-0600 receive FDA 510(k) clearance?

TRIO MONITOR MODEL 0998-00-0600 received FDA 510(k) clearance on 2004-02-11, under 510(k) number K032338.

Who is the listed applicant for TRIO MONITOR MODEL 0998-00-0600?

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 TRIO MONITOR MODEL 0998-00-0600?

The FDA product code for TRIO MONITOR MODEL 0998-00-0600 is MWI.

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Related Devices (Code: MWI)

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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.

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