Finger Clip Pulse Oximeter

FDA 510(k) Premarket Notification · Submission K231243 · Applicant: Guangdong Genial Technology Co., Ltd.

Public Record 510(k) Submission Decision Date: 2023-10-31 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K231243.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K231243
Device Name
Finger Clip Pulse Oximeter
Product Code
DQA
Decision Date
2023-10-31
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Cardiovascular (CV)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2023-05-01

Related Establishments / Registrations

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