BreathID Smart System

by Exalenz Bioscience, Ltd. 510(k)

Active United States

510(k) K193610

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK193610	Date6 Feb 2020Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number: K193610
FDA Product Code: MSQ
FDA applicant: Exalenz Bioscience , Ltd.

Device Class: Class I
Regulation: 21 CFR Part 866.3110
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

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