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FDA 510(k)

Quantum Mini Ventilation Module

K-Number: K210669 · 2021-05-04

ApplicantSpectrum Medical , Ltd.
Decision Date2021-05-04
Product CodeDTX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Mini Ventilation Module 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 2021-05-04 under 510(k) number K210669. The device is classified under product code DTX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Mini Ventilation Module?

Quantum Mini Ventilation Module is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K210669.

When did Quantum Mini Ventilation Module receive FDA 510(k) clearance?

Quantum Mini Ventilation Module received FDA 510(k) clearance on 2021-05-04, under 510(k) number K210669.

Who is the listed applicant for Quantum Mini Ventilation Module?

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 Mini Ventilation Module?

The FDA product code for Quantum Mini Ventilation Module is DTX.

Other records listing Spectrum Medical , Ltd. as applicant

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Related Devices (Code: DTX)

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.

K202733Quantum Ventilation ModuleSpectrum Medical , Ltd.K181942Quantum Ventilation ModuleSpectrum 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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