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FDA 510(k)

INFINITY MASIMO SET SP02 POD

K-Number: K061329 · 2006-07-07

ApplicantDraeger Medical Systems, Inc.
Decision Date2006-07-07
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY MASIMO SET SP02 POD 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 2006-07-07 under 510(k) number K061329. 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 MASIMO SET SP02 POD?

INFINITY MASIMO SET SP02 POD is a medical device that received FDA 510(k) clearance on 2006-07-07. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K061329.

When did INFINITY MASIMO SET SP02 POD receive FDA 510(k) clearance?

INFINITY MASIMO SET SP02 POD received FDA 510(k) clearance on 2006-07-07, under 510(k) number K061329.

Who is the listed applicant for INFINITY MASIMO SET SP02 POD?

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 MASIMO SET SP02 POD?

The FDA product code for INFINITY MASIMO SET SP02 POD 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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