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FDA 510(k)

INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997

K-Number: K082888 · 2008-11-26

ApplicantDraeger Medical Systems, Inc.
Decision Date2008-11-26
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-11-26 under 510(k) number K082888. 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 INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997?

INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 is a medical device that received FDA 510(k) clearance on 2008-11-26. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K082888.

When did INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 receive FDA 510(k) clearance?

INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 received FDA 510(k) clearance on 2008-11-26, under 510(k) number K082888.

Who is the listed applicant for INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997?

The FDA 510(k) record lists Draeger Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997?

The FDA product code for INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 is 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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