510(k) K240229

Device: Masimo W1
Applicant: Masimo Corporation
510(k) number: K240229
Product code: DPS
Decision: Substantially Equivalent (SESE)
Decision date: 2024-08-08
Date received: 2024-01-29
Regulation: 870.2340
Classification name: Electrocardiograph
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N
Source: FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact: Sindura Penubarthi
Address: 52 Discovery Irvine CA US 92618 92618

FDA Registration Numbers

3005877899
9710602
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1218950
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Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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