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FDA 510(k)

NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01

K-Number: K080175 · 2008-06-09

ApplicantDatascope Corp., Patient Monitoring Division
Decision Date2008-06-09
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 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 2008-06-09 under 510(k) number K080175. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01?

NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 is a medical device that received FDA 510(k) clearance on 2008-06-09. The listed applicant is Datascope Corp., Patient Monitoring Division. The 510(k) number is K080175.

When did NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 receive FDA 510(k) clearance?

NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 received FDA 510(k) clearance on 2008-06-09, under 510(k) number K080175.

Who is the listed applicant for NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01?

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 NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01?

The FDA product code for NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 is BSZ.

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 SYSTEMK091834PASSPORT V MONITOR, MODEL 0998-00-6100K091068ACCUTORR V MONITOR, MODEL 0998-00-2000

Related Devices (Code: BSZ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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