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FDA 510(k)

TENACORE SP02 SENSORS

K-Number: K053420 · 2006-11-15

ApplicantTenacore Holdings, Inc.
Decision Date2006-11-15
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TENACORE SP02 SENSORS is the device name listed in this FDA 510(k) record. The listed applicant is Tenacore Holdings, Inc.. It received FDA 510(k) clearance on 2006-11-15 under 510(k) number K053420. 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 TENACORE SP02 SENSORS?

TENACORE SP02 SENSORS is a medical device that received FDA 510(k) clearance on 2006-11-15. The listed applicant is Tenacore Holdings, Inc.. The 510(k) number is K053420.

When did TENACORE SP02 SENSORS receive FDA 510(k) clearance?

TENACORE SP02 SENSORS received FDA 510(k) clearance on 2006-11-15, under 510(k) number K053420.

Who is the listed applicant for TENACORE SP02 SENSORS?

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

What is the FDA product code for TENACORE SP02 SENSORS?

The FDA product code for TENACORE SP02 SENSORS is DQA.

Related Clinical Trials

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Other records listing Tenacore Holdings, 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.

K081335TENACORE OXYGEN BLENDER, MODEL TB-2000K043075TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGK012041THE HAMMER MODEL H100

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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