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FDA 510(k)

DIXTAL DZ-4100 SERIES PULSE OXIMETER

K-Number: K103285 · 2011-07-25

ApplicantDixtal Medical, Inc.
Decision Date2011-07-25
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIXTAL DZ-4100 SERIES PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Dixtal Medical, Inc.. It received FDA 510(k) clearance on 2011-07-25 under 510(k) number K103285. 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 DIXTAL DZ-4100 SERIES PULSE OXIMETER?

DIXTAL DZ-4100 SERIES PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2011-07-25. The listed applicant is Dixtal Medical, Inc.. The 510(k) number is K103285.

When did DIXTAL DZ-4100 SERIES PULSE OXIMETER receive FDA 510(k) clearance?

DIXTAL DZ-4100 SERIES PULSE OXIMETER received FDA 510(k) clearance on 2011-07-25, under 510(k) number K103285.

Who is the listed applicant for DIXTAL DZ-4100 SERIES PULSE OXIMETER?

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

What is the FDA product code for DIXTAL DZ-4100 SERIES PULSE OXIMETER?

The FDA product code for DIXTAL DZ-4100 SERIES PULSE OXIMETER 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 Dixtal Medical, 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.

K100020DX SERIES FINGER SENSOR

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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