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FDA 510(k)

PASSPORT V MONITOR, MODEL 0998-00-6100

K-Number: K091834 · 2009-07-15

ApplicantDatascope Corp., Patient Monitoring Division
Decision Date2009-07-15
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PASSPORT V MONITOR, MODEL 0998-00-6100 is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp., Patient Monitoring Division. It received FDA 510(k) clearance on 2009-07-15 under 510(k) number K091834. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASSPORT V MONITOR, MODEL 0998-00-6100?

PASSPORT V MONITOR, MODEL 0998-00-6100 is a medical device that received FDA 510(k) clearance on 2009-07-15. The listed applicant is Datascope Corp., Patient Monitoring Division. The 510(k) number is K091834.

When did PASSPORT V MONITOR, MODEL 0998-00-6100 receive FDA 510(k) clearance?

PASSPORT V MONITOR, MODEL 0998-00-6100 received FDA 510(k) clearance on 2009-07-15, under 510(k) number K091834.

Who is the listed applicant for PASSPORT V MONITOR, MODEL 0998-00-6100?

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

What is the FDA product code for PASSPORT V MONITOR, MODEL 0998-00-6100?

The FDA product code for PASSPORT V MONITOR, MODEL 0998-00-6100 is MHX.

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.

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Other records listing Datascope Corp., Patient Monitoring Division 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.

K123211A5 ANESTHESIA DELIVERY SYSTEMK091068ACCUTORR V MONITOR, MODEL 0998-00-2000K080175NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01

Related Devices (Code: MHX)

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.

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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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