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FDA 510(k)

DATA MASTER PERFUSION MONITORING SYSTEM

K-Number: K001388 · 2000-07-28

ApplicantDideco
Decision Date2000-07-28
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATA MASTER PERFUSION MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dideco. It received FDA 510(k) clearance on 2000-07-28 under 510(k) number K001388. 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 DATA MASTER PERFUSION MONITORING SYSTEM?

DATA MASTER PERFUSION MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2000-07-28. The listed applicant is Dideco. The 510(k) number is K001388.

When did DATA MASTER PERFUSION MONITORING SYSTEM receive FDA 510(k) clearance?

DATA MASTER PERFUSION MONITORING SYSTEM received FDA 510(k) clearance on 2000-07-28, under 510(k) number K001388.

Who is the listed applicant for DATA MASTER PERFUSION MONITORING SYSTEM?

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

What is the FDA product code for DATA MASTER PERFUSION MONITORING SYSTEM?

The FDA product code for DATA MASTER PERFUSION MONITORING SYSTEM is DRY.

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 Dideco 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.

K004001MONOLYTH MIMESYS HOLLOW FIBER OXYGENATORK010478DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SURK936220DIDECO VACUUM PUMPK940519DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM

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

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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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