REGULATOR-INHALATOR SYSTEM— 510(k) K853971

Substantially Equivalent

Stephenson Industries, Inc.

FDA 510(k) clearance K853971 for REGULATOR-INHALATOR SYSTEM, Substantially Equivalent on 1985-12-09. Applicant: Stephenson Industries, Inc..

Clearance details

Applicant: Stephenson Industries, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1985-09-26
Decision date: 1985-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NJ, US

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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.