Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas

K-Number: K173591 · 2018-03-28

ApplicantSpectrum Medical , Ltd.
Decision Date2018-03-28
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K173591. 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 Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K173591.

When did Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas receive FDA 510(k) clearance?

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas received FDA 510(k) clearance on 2018-03-28, under 510(k) number K173591.

Who is the listed applicant for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

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

What is the FDA product code for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

The FDA product code for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is DRY.

Other records listing Spectrum Medical , Ltd. 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.

K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)K212657Quantum Heater-CoolerK210669Quantum Mini Ventilation ModuleK202733Quantum Ventilation ModuleK202557Quantum Workstation 12 EliteK192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

View all 12 devices →

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.K163657Quantum WorkstationSpectrum 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.

↑