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FDA 510(k)

NELLCOR OXIMAX N-600X PULSE OXIMETER

K-Number: K060576 · 2006-08-14

ApplicantNellcor Puritan Bennett, Inc.
Decision Date2006-08-14
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NELLCOR OXIMAX N-600X 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 2006-08-14 under 510(k) number K060576. 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 NELLCOR OXIMAX N-600X PULSE OXIMETER?

NELLCOR OXIMAX N-600X PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2006-08-14. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K060576.

When did NELLCOR OXIMAX N-600X PULSE OXIMETER receive FDA 510(k) clearance?

NELLCOR OXIMAX N-600X PULSE OXIMETER received FDA 510(k) clearance on 2006-08-14, under 510(k) number K060576.

Who is the listed applicant for NELLCOR OXIMAX N-600X 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 NELLCOR OXIMAX N-600X PULSE OXIMETER?

The FDA product code for NELLCOR OXIMAX N-600X PULSE OXIMETER 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 SENSORK051271OXIMAX 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.

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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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