SAMSON'S NEWBORN LUNG INFLATOR 340-1000— 510(k) K842487

Substantially Equivalent

J. H. Emerson Co.

FDA 510(k) clearance K842487 for SAMSON'S NEWBORN LUNG INFLATOR 340-1000, Substantially Equivalent on 1984-07-06. Applicant: J. H. Emerson Co..

Clearance details

Applicant: J. H. Emerson Co.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1984-06-26
Decision date: 1984-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.