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FDA 510(k)

DURAMAX REUSABLE OXIMETRY SENSOR

K-Number: K070408 · 2007-05-25

ApplicantNellcor Puritan Bennett, Inc.
Decision Date2007-05-25
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DURAMAX REUSABLE OXIMETRY SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K070408. 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 DURAMAX REUSABLE OXIMETRY SENSOR?

DURAMAX REUSABLE OXIMETRY SENSOR is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K070408.

When did DURAMAX REUSABLE OXIMETRY SENSOR receive FDA 510(k) clearance?

DURAMAX REUSABLE OXIMETRY SENSOR received FDA 510(k) clearance on 2007-05-25, under 510(k) number K070408.

Who is the listed applicant for DURAMAX REUSABLE OXIMETRY SENSOR?

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

What is the FDA product code for DURAMAX REUSABLE OXIMETRY SENSOR?

The FDA product code for DURAMAX REUSABLE OXIMETRY SENSOR is DQA.

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Other records listing Nellcor Puritan Bennett, 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.

K060576NELLCOR OXIMAX N-600X PULSE OXIMETERK051271OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSORK052186NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-PK051352OXIMAX NPB-40 HANDHELD PULSE OXIMETERK050072GOODKNIGHT 425STK033973OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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