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FDA 510(k)

TRUSIGNAL SPO2 FINGERTIP SENSOR

K-Number: K101871 · 2010-10-04

ApplicantGE Healthcare Finland Oy
Decision Date2010-10-04
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRUSIGNAL SPO2 FINGERTIP SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2010-10-04 under 510(k) number K101871. 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 TRUSIGNAL SPO2 FINGERTIP SENSOR?

TRUSIGNAL SPO2 FINGERTIP SENSOR is a medical device that received FDA 510(k) clearance on 2010-10-04. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K101871.

When did TRUSIGNAL SPO2 FINGERTIP SENSOR receive FDA 510(k) clearance?

TRUSIGNAL SPO2 FINGERTIP SENSOR received FDA 510(k) clearance on 2010-10-04, under 510(k) number K101871.

Who is the listed applicant for TRUSIGNAL SPO2 FINGERTIP SENSOR?

The FDA 510(k) record lists GE Healthcare Finland Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUSIGNAL SPO2 FINGERTIP SENSOR?

The FDA product code for TRUSIGNAL SPO2 FINGERTIP SENSOR is DQA.

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Other records listing GE Healthcare Finland Oy 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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