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FDA 510(k)

LNCS OXIMETRY SENSORS

K-Number: K041815 · 2004-07-29

ApplicantMasimo Corp.
Decision Date2004-07-29
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LNCS OXIMETRY SENSORS is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corp.. It received FDA 510(k) clearance on 2004-07-29 under 510(k) number K041815. 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 LNCS OXIMETRY SENSORS?

LNCS OXIMETRY SENSORS is a medical device that received FDA 510(k) clearance on 2004-07-29. The listed applicant is Masimo Corp.. The 510(k) number is K041815.

When did LNCS OXIMETRY SENSORS receive FDA 510(k) clearance?

LNCS OXIMETRY SENSORS received FDA 510(k) clearance on 2004-07-29, under 510(k) number K041815.

Who is the listed applicant for LNCS OXIMETRY SENSORS?

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

What is the FDA product code for LNCS OXIMETRY SENSORS?

The FDA product code for LNCS OXIMETRY SENSORS is DQA.

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Other records listing Masimo Corp. 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.

K041204NC SP02 ADAPTER CABLEK040259MASIMO SET INTELLIVUE PULSE OXIMETER MODULEK033998MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5VK040214MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESK032551MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSORK033296MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V

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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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