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FDA 510(k)

PULSE OXIMETER MODEL P10

K-Number: K100225 · 2011-02-09

ApplicantMediana Co., Ltd.
Decision Date2011-02-09
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE OXIMETER MODEL P10 is the device name listed in this FDA 510(k) record. The listed applicant is Mediana Co., Ltd.. It received FDA 510(k) clearance on 2011-02-09 under 510(k) number K100225. 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 PULSE OXIMETER MODEL P10?

PULSE OXIMETER MODEL P10 is a medical device that received FDA 510(k) clearance on 2011-02-09. The listed applicant is Mediana Co., Ltd.. The 510(k) number is K100225.

When did PULSE OXIMETER MODEL P10 receive FDA 510(k) clearance?

PULSE OXIMETER MODEL P10 received FDA 510(k) clearance on 2011-02-09, under 510(k) number K100225.

Who is the listed applicant for PULSE OXIMETER MODEL P10?

The FDA 510(k) record lists Mediana Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSE OXIMETER MODEL P10?

The FDA product code for PULSE OXIMETER MODEL P10 is DQA.

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Other records listing Mediana Co., Ltd. as applicant

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K200434V20, V20a, AVSM3 SNFK170497V10K160358DT-100K152659V10K112190PATIENT MONITORK110612FM20

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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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