FDA Device Intelligence
Home › A-M SYSTEMS, LLC › Breathebite Mouthpiece

Breathebite Mouthpiece

A-M SYSTEMS, LLC · Model Breathebite Mouthpiece - 164951 · UDI-DI 00817081027198

BYP Prescription
10
510(k) clearances
13
Adverse events (1 deaths)
0
Recalls
167
Facilities

Description

Breathebite Disposable Mouthpiece

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.