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FDA 510(k)

SPO2 OPTION

K-Number: K902730 · 1990-10-22

ApplicantProtocol Systems, Inc.
Decision Date1990-10-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPO2 OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Protocol Systems, Inc.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K902730. 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 SPO2 OPTION?

SPO2 OPTION is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Protocol Systems, Inc.. The 510(k) number is K902730.

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

SPO2 OPTION received FDA 510(k) clearance on 1990-10-22, under 510(k) number K902730.

Who is the listed applicant for SPO2 OPTION?

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

What is the FDA product code for SPO2 OPTION?

The FDA product code for SPO2 OPTION is DQA.

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Other records listing Protocol Systems, Inc. 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.

K002725MICROPAQ, MODELS 402 AND 404K972121ACUITY CENTRAL STATIONK951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSK945071PROPAQ 200 MONITORK935846MODEL ACUITY CENTRAL STATIONK934711PROPAQ ECG TELEMETRY OPTION

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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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