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FDA 510(k)

KONICA MINOLTA PULSOX-300, 300I

K-Number: K053419 · 2006-05-11

ApplicantKonica Minolta Sensing, Inc.
Decision Date2006-05-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KONICA MINOLTA PULSOX-300, 300I is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta Sensing, Inc.. It received FDA 510(k) clearance on 2006-05-11 under 510(k) number K053419. 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 KONICA MINOLTA PULSOX-300, 300I?

KONICA MINOLTA PULSOX-300, 300I is a medical device that received FDA 510(k) clearance on 2006-05-11. The listed applicant is Konica Minolta Sensing, Inc.. The 510(k) number is K053419.

When did KONICA MINOLTA PULSOX-300, 300I receive FDA 510(k) clearance?

KONICA MINOLTA PULSOX-300, 300I received FDA 510(k) clearance on 2006-05-11, under 510(k) number K053419.

Who is the listed applicant for KONICA MINOLTA PULSOX-300, 300I?

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

What is the FDA product code for KONICA MINOLTA PULSOX-300, 300I?

The FDA product code for KONICA MINOLTA PULSOX-300, 300I is DQA.

Related Clinical Trials

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Other records listing Konica Minolta Sensing, 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.

K021469MINOLTA PULSOX-2K010413MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI

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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