iHealth Clinical Digital Thermometer

by Andon Health Co., Ltd. 510(k)

Active United States

510(k) K202791

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Abbreviated	NumberK202791	Date5 Jan 2021Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K202791
FDA Product Code: FLL
FDA applicant: Andon Health Co, Ltd.

Device Class: Class II
Regulation: 21 CFR Part 880.2910
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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