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FDA 510(k)

SENTINEL PULSE OXIMETER

K-Number: K880672 · 1988-05-06

ApplicantSentinel Monitoring Technologies, Ltd.
Decision Date1988-05-06
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENTINEL PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Sentinel Monitoring Technologies, Ltd.. It received FDA 510(k) clearance on 1988-05-06 under 510(k) number K880672. 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 SENTINEL PULSE OXIMETER?

SENTINEL PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1988-05-06. The listed applicant is Sentinel Monitoring Technologies, Ltd.. The 510(k) number is K880672.

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

SENTINEL PULSE OXIMETER received FDA 510(k) clearance on 1988-05-06, under 510(k) number K880672.

Who is the listed applicant for SENTINEL PULSE OXIMETER?

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

What is the FDA product code for SENTINEL PULSE OXIMETER?

The FDA product code for SENTINEL PULSE OXIMETER is DQA.

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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

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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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