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FDA 510(k)

SPIROPRO SPO2

K-Number: K031515 · 2003-11-14

ApplicantViasys Healthcare GmbH
Decision Date2003-11-14
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPIROPRO SPO2 is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Healthcare GmbH. It received FDA 510(k) clearance on 2003-11-14 under 510(k) number K031515. 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 SPIROPRO SPO2?

SPIROPRO SPO2 is a medical device that received FDA 510(k) clearance on 2003-11-14. The listed applicant is Viasys Healthcare GmbH. The 510(k) number is K031515.

When did SPIROPRO SPO2 receive FDA 510(k) clearance?

SPIROPRO SPO2 received FDA 510(k) clearance on 2003-11-14, under 510(k) number K031515.

Who is the listed applicant for SPIROPRO SPO2?

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

What is the FDA product code for SPIROPRO SPO2?

The FDA product code for SPIROPRO SPO2 is DQA.

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Other records listing Viasys Healthcare GmbH 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.

K092324SPIROPROK091412CLEAN PEAK FLOW METERK091505COR12+K081823MASTERSCREEN PAED - BABY BODYK080510VIP PULMONARY FUNCTION SYSTEMK080734FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT

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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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