Tidal Wave Sp (710 +2 more) - 715

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032971

Identifiers

510(k) Number: K032971 FDA 510(k)
FDA Product Code: DQA FDA 510(k)
Models / Variants: 710 FDA 510(k)
715 FDA 510(k)
715 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.2700 FDA 510(k)
Regulation Number: 870.2700 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Tidal Wave Sp (710 +2 more) - 715 by Respironics Novametrix, LLC — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K032971	Class II	Active

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Manufacturer

Manufacturer: Respironics Novametrix, LLC
FDA Applicant: Respironics Novametrix, Inc.

Sources (1)

FDA 510(k) K032971 24 fields · synced Jun 18, 2026