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APPS-HEALTH01

by Andon Health Co., Ltd.

510(k) K122098

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122098 Date21 Mar 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
FDA applicant
Andon Health Co, Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

APPS-HEALTH01 is a noninvasive blood oximeter intended for monitoring oxygen saturation levels in the blood. It is designed to provide accurate and reliable readings for personal health management.

The device is supplied as a single-use, non-reusable item and is not sterilized. It is not MRI safe and is available in a single size. The device is authorized for use in the United States under FDA 510(k) clearance.

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