MULTIICHALLENGE NEBULIZER SYSTEM— 510(k) K883704

Substantially Equivalent

Biotrine Corp.

FDA 510(k) clearance K883704 for MULTIICHALLENGE NEBULIZER SYSTEM, Substantially Equivalent on 1988-11-28. Applicant: Biotrine Corp..

Clearance details

Applicant: Biotrine Corp.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1988-08-30
Decision date: 1988-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.