Source document or public record
FDA 510(k) K193610 — BreathID Smart System
FDA 510(k) index record K193610. Device: BreathID Smart System. Applicant as listed: Exalenz Bioscience , Ltd.. Decision date: 2020-02-06.
Source
"device_name": "BreathID Smart System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K193610.
Device name: BreathID Smart System. Applicant as listed: Exalenz Bioscience , Ltd..
Decision date: 2020-02-06. Decision wording: Substantially Equivalent.
Product code: MSQ. Regulation: 21 CFR 866.3110. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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