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FDA 510(k)

SENTEC DIGITAL MONITORING SYSTEM

K-Number: K071672 · 2007-09-12

ApplicantSentec AG
Decision Date2007-09-12
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENTEC DIGITAL MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sentec AG. It received FDA 510(k) clearance on 2007-09-12 under 510(k) number K071672. 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 SENTEC DIGITAL MONITORING SYSTEM?

SENTEC DIGITAL MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-09-12. The listed applicant is Sentec AG. The 510(k) number is K071672.

When did SENTEC DIGITAL MONITORING SYSTEM receive FDA 510(k) clearance?

SENTEC DIGITAL MONITORING SYSTEM received FDA 510(k) clearance on 2007-09-12, under 510(k) number K071672.

Who is the listed applicant for SENTEC DIGITAL MONITORING SYSTEM?

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

What is the FDA product code for SENTEC DIGITAL MONITORING SYSTEM?

The FDA product code for SENTEC DIGITAL MONITORING SYSTEM is DQA.

Related Clinical Trials

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.

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Other records listing Sentec AG 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.

K243765LuMon(TM) SystemK232516Sentec Digital Monitoring System (SDMS) tCOM+K101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE

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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