MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR— 510(k) K844420

Substantially Equivalent

Med-Life, Inc.

FDA 510(k) clearance K844420 for MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR, Substantially Equivalent on 1984-12-17. Applicant: Med-Life, Inc..

Clearance details

Applicant: Med-Life, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1984-11-15
Decision date: 1984-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bryan, TX, US

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.