MOUTH TO FACE RESUSCITATOR— 510(k) K873043

Substantially Equivalent

Artec Environmental Monitoring Division

FDA 510(k) clearance K873043 for MOUTH TO FACE RESUSCITATOR, Substantially Equivalent on 1987-09-28. Applicant: Artec Environmental Monitoring Division.

Clearance details

Applicant: Artec Environmental Monitoring Division
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1987-08-04
Decision date: 1987-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noblesville, IN, 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.