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FDA 510(k)

BCI WW1030 PULSE OXIMETER

K-Number: K083557 · 2009-05-01

ApplicantSmiths Medical Pm, Inc.
Decision Date2009-05-01
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BCI WW1030 PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Pm, Inc.. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K083557. 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 BCI WW1030 PULSE OXIMETER?

BCI WW1030 PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Smiths Medical Pm, Inc.. The 510(k) number is K083557.

When did BCI WW1030 PULSE OXIMETER receive FDA 510(k) clearance?

BCI WW1030 PULSE OXIMETER received FDA 510(k) clearance on 2009-05-01, under 510(k) number K083557.

Who is the listed applicant for BCI WW1030 PULSE OXIMETER?

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

What is the FDA product code for BCI WW1030 PULSE OXIMETER?

The FDA product code for BCI WW1030 PULSE OXIMETER 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Smiths Medical Pm, 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.

K090205BCI WW1021 PC APPLICATIONK083787BCI WW1000 PULSE OXIMETER, MODEL WW1000K083705BCI WW1020 PULSE OXIMETER, MODEL WW1020K070732BCI AUTOCON 3304 DIGITAL PULSE OXIMETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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