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FDA 510(k)

PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX

K-Number: K993531 · 2000-01-13

ApplicantDatascope Corp.
Decision Date2000-01-13
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2000-01-13 under 510(k) number K993531. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX?

PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX is a medical device that received FDA 510(k) clearance on 2000-01-13. The listed applicant is Datascope Corp.. The 510(k) number is K993531.

When did PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX receive FDA 510(k) clearance?

PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX received FDA 510(k) clearance on 2000-01-13, under 510(k) number K993531.

Who is the listed applicant for PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX?

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 PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX?

The FDA product code for PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX is DSI.

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Related Devices (Code: DSI)

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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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