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FDA 510(k)

MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1

K-Number: K101031 · 2010-11-18

ApplicantMasimo Corporation
Decision Date2010-11-18
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2010-11-18 under 510(k) number K101031. 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 MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1?

MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 is a medical device that received FDA 510(k) clearance on 2010-11-18. The listed applicant is Masimo Corporation. The 510(k) number is K101031.

When did MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 receive FDA 510(k) clearance?

MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 received FDA 510(k) clearance on 2010-11-18, under 510(k) number K101031.

Who is the listed applicant for MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1?

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

What is the FDA product code for MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1?

The FDA product code for MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 is DQA.

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Other records listing Masimo Corporation as applicant

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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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