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FDA 510(k)

MIROXI

K-Number: K081033 · 2009-01-15

ApplicantMir Medical Intl. Research Srl
Decision Date2009-01-15
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MIROXI is the device name listed in this FDA 510(k) record. The listed applicant is Mir Medical Intl. Research Srl. It received FDA 510(k) clearance on 2009-01-15 under 510(k) number K081033. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIROXI?

MIROXI is a medical device that received FDA 510(k) clearance on 2009-01-15. The listed applicant is Mir Medical Intl. Research Srl. The 510(k) number is K081033.

When did MIROXI receive FDA 510(k) clearance?

MIROXI received FDA 510(k) clearance on 2009-01-15, under 510(k) number K081033.

Who is the listed applicant for MIROXI?

The FDA 510(k) record lists Mir Medical Intl. Research Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIROXI?

The FDA product code for MIROXI is DQA.

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Other records listing Mir Medical Intl. Research Srl 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.

K130784SPIROTELK122384MINISPIRK082766MODIFICATION TO MINISPIR, SPIROLAB IIIK072979SPIROBANK GK061875MINISPIR; SPIROLAB IIIK061712SPIROBANK II

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Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., 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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