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FDA 510(k)

OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N

K-Number: K030930 · 2003-05-23

ApplicantNellcor Puritan Bennett, Inc.
Decision Date2003-05-23
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N 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 2003-05-23 under 510(k) number K030930. 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 SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N?

OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N is a medical device that received FDA 510(k) clearance on 2003-05-23. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K030930.

When did OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N receive FDA 510(k) clearance?

OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N received FDA 510(k) clearance on 2003-05-23, under 510(k) number K030930.

Who is the listed applicant for OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N?

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 SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N?

The FDA product code for OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N is DQA.

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Related Devices (Code: DQA)

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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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