iHealth BP3L Wireless Blood Pressure Monitor

FDA 510(k) Premarket Notification · Submission K152003 · Applicant: Andon Health Co, Ltd.

Public Record 510(k) Submission Decision Date: 2015-09-24 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K152003.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K152003
Applicant / Sponsor
Device Name
iHealth BP3L Wireless Blood Pressure Monitor
Product Code
DXN
Decision Date
2015-09-24
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Cardiovascular (CV)
Clearance Type
Special
Third Party Flag
N
Date Received
2015-07-20

Related Establishments / Registrations

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