RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR— 510(k) K853083

Substantially Equivalent

Home Medical Supply, Inc.

FDA 510(k) clearance K853083 for RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR, Substantially Equivalent on 1985-09-03. Applicant: Home Medical Supply, Inc..

Clearance details

Applicant: Home Medical Supply, Inc.
Product code: Code BYJ
Advisory panel: Anesthesiology
Date received: 1985-07-23
Decision date: 1985-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearfield, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

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.