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FDA 510(k)

DATASCOPE PASSPORT MONITOR

K-Number: K911598 · 1991-10-15

ApplicantDatascope Corp.
Decision Date1991-10-15
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATASCOPE PASSPORT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K911598. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATASCOPE PASSPORT MONITOR?

DATASCOPE PASSPORT MONITOR is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Datascope Corp.. The 510(k) number is K911598.

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

DATASCOPE PASSPORT MONITOR received FDA 510(k) clearance on 1991-10-15, under 510(k) number K911598.

Who is the listed applicant for DATASCOPE PASSPORT MONITOR?

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?

The FDA product code for DATASCOPE PASSPORT MONITOR is DRT.

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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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