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FDA 510(k)

TIDAL WAVE SP MODEL 710/715 AND 715

K-Number: K032971 · 2004-08-26

ApplicantRespironics Novametrix, Inc.
Decision Date2004-08-26
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TIDAL WAVE SP MODEL 710/715 AND 715 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Novametrix, Inc.. It received FDA 510(k) clearance on 2004-08-26 under 510(k) number K032971. 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 TIDAL WAVE SP MODEL 710/715 AND 715?

TIDAL WAVE SP MODEL 710/715 AND 715 is a medical device that received FDA 510(k) clearance on 2004-08-26. The listed applicant is Respironics Novametrix, Inc.. The 510(k) number is K032971.

When did TIDAL WAVE SP MODEL 710/715 AND 715 receive FDA 510(k) clearance?

TIDAL WAVE SP MODEL 710/715 AND 715 received FDA 510(k) clearance on 2004-08-26, under 510(k) number K032971.

Who is the listed applicant for TIDAL WAVE SP MODEL 710/715 AND 715?

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

What is the FDA product code for TIDAL WAVE SP MODEL 710/715 AND 715?

The FDA product code for TIDAL WAVE SP MODEL 710/715 AND 715 is DQA.

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Other records listing Respironics Novametrix, Inc. as applicant

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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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