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FDA 510(k)

OXIMAX NPB-40 HANDHELD PULSE OXIMETER

K-Number: K051352 · 2005-08-11

ApplicantNellcor Puritan Bennett, Inc.
Decision Date2005-08-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXIMAX NPB-40 HANDHELD PULSE OXIMETER 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 2005-08-11 under 510(k) number K051352. 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 NPB-40 HANDHELD PULSE OXIMETER?

OXIMAX NPB-40 HANDHELD PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2005-08-11. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K051352.

When did OXIMAX NPB-40 HANDHELD PULSE OXIMETER receive FDA 510(k) clearance?

OXIMAX NPB-40 HANDHELD PULSE OXIMETER received FDA 510(k) clearance on 2005-08-11, under 510(k) number K051352.

Who is the listed applicant for OXIMAX NPB-40 HANDHELD PULSE OXIMETER?

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 NPB-40 HANDHELD PULSE OXIMETER?

The FDA product code for OXIMAX NPB-40 HANDHELD 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.

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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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