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FDA 510(k)

SATURATION/HEMATOCRIT MONITOR SYSTEM

K-Number: K910421 · 1991-10-15

ApplicantMedtronic Vascular
Decision Date1991-10-15
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SATURATION/HEMATOCRIT MONITOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K910421. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATURATION/HEMATOCRIT MONITOR SYSTEM?

SATURATION/HEMATOCRIT MONITOR SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Medtronic Vascular. The 510(k) number is K910421.

When did SATURATION/HEMATOCRIT MONITOR SYSTEM receive FDA 510(k) clearance?

SATURATION/HEMATOCRIT MONITOR SYSTEM received FDA 510(k) clearance on 1991-10-15, under 510(k) number K910421.

Who is the listed applicant for SATURATION/HEMATOCRIT MONITOR SYSTEM?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SATURATION/HEMATOCRIT MONITOR SYSTEM?

The FDA product code for SATURATION/HEMATOCRIT MONITOR SYSTEM is DRY.

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Related Devices (Code: DRY)

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.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.

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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