FDA 510(k)

PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER

K-Number: K033715 · 2004-02-13

Decision Date2004-02-13

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-02-13 under 510(k) number K033715. 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 SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER?

PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER is a medical device that received FDA 510(k) clearance on 2004-02-13. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K033715.

When did PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER receive FDA 510(k) clearance?

PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER received FDA 510(k) clearance on 2004-02-13, under 510(k) number K033715.

Who is the listed applicant for PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER?

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

What is the FDA product code for PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER?

The FDA product code for PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER is DQA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Philips Medical Systems, Inc. as applicant

K093355PCR ELEVA 1.2 K090808PINNACLE3 SMARTARC K071391PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 K063783PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A K041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN K040955M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN

View all 111 devices →

Related Devices (Code: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse 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 Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita Corporation K252805YUWELL® 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.