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FDA 510(k)

PICOSAT II SPO2 PULSE OXIMETRY MODULE

K-Number: K030973 · 2003-07-23

ApplicantPhilips Medical Systems
Decision Date2003-07-23
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PICOSAT II SPO2 PULSE OXIMETRY MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2003-07-23 under 510(k) number K030973. 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 PICOSAT II SPO2 PULSE OXIMETRY MODULE?

PICOSAT II SPO2 PULSE OXIMETRY MODULE is a medical device that received FDA 510(k) clearance on 2003-07-23. The listed applicant is Philips Medical Systems. The 510(k) number is K030973.

When did PICOSAT II SPO2 PULSE OXIMETRY MODULE receive FDA 510(k) clearance?

PICOSAT II SPO2 PULSE OXIMETRY MODULE received FDA 510(k) clearance on 2003-07-23, under 510(k) number K030973.

Who is the listed applicant for PICOSAT II SPO2 PULSE OXIMETRY MODULE?

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

What is the FDA product code for PICOSAT II SPO2 PULSE OXIMETRY MODULE?

The FDA product code for PICOSAT II SPO2 PULSE OXIMETRY MODULE is DQA.

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Other records listing Philips Medical Systems 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.

K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemK211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemK210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 CardiographK191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 CardiographK192875Philips Biosensor BX100K183387M3290B Patient Information Center iX

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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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