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FDA 510(k)

WAVE Clinical Platform

K-Number: K171056 · 2018-01-04

ApplicantExcel Medical Electronics, LLC
Decision Date2018-01-04
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WAVE Clinical Platform is the device name listed in this FDA 510(k) record. The listed applicant is Excel Medical Electronics, LLC. It received FDA 510(k) clearance on 2018-01-04 under 510(k) number K171056. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVE Clinical Platform?

WAVE Clinical Platform is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Excel Medical Electronics, LLC. The 510(k) number is K171056.

When did WAVE Clinical Platform receive FDA 510(k) clearance?

WAVE Clinical Platform received FDA 510(k) clearance on 2018-01-04, under 510(k) number K171056.

Who is the listed applicant for WAVE Clinical Platform?

The FDA 510(k) record lists Excel Medical Electronics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVE Clinical Platform?

The FDA product code for WAVE Clinical Platform is MWI.

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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