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FDA 510(k)

OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR

K-Number: K021089 · 2002-06-19

ApplicantNellcor Puritan Bennett, Inc.
Decision Date2002-06-19
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXIMAX MAX-FAST ADHESIVE FOREHEAD 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 2002-06-19 under 510(k) number K021089. 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 OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR?

OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR is a medical device that received FDA 510(k) clearance on 2002-06-19. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K021089.

When did OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR receive FDA 510(k) clearance?

OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR received FDA 510(k) clearance on 2002-06-19, under 510(k) number K021089.

Who is the listed applicant for OXIMAX MAX-FAST ADHESIVE FOREHEAD 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 OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR?

The FDA product code for OXIMAX MAX-FAST ADHESIVE FOREHEAD 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.

K070408DURAMAX REUSABLE OXIMETRY SENSORK060576NELLCOR 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 425ST

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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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