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FDA 510(k)

OXICARE FINGERTIP PULSE OXIMETER

K-Number: K122927 · 2012-12-20

ApplicantDelbio Incorporated
Decision Date2012-12-20
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXICARE FINGERTIP PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Delbio Incorporated. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K122927. 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 OXICARE FINGERTIP PULSE OXIMETER?

OXICARE FINGERTIP PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Delbio Incorporated. The 510(k) number is K122927.

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

OXICARE FINGERTIP PULSE OXIMETER received FDA 510(k) clearance on 2012-12-20, under 510(k) number K122927.

Who is the listed applicant for OXICARE FINGERTIP PULSE OXIMETER?

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

What is the FDA product code for OXICARE FINGERTIP PULSE OXIMETER?

The FDA product code for OXICARE FINGERTIP 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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