AMEDA NEONATAL RESUSCITATION UNIT-— 510(k) K832637

Substantially Equivalent

Egnell, Inc.

FDA 510(k) clearance K832637 for AMEDA NEONATAL RESUSCITATION UNIT-, Substantially Equivalent on 1983-12-22. Applicant: Egnell, Inc..

Clearance details

Applicant: Egnell, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1983-08-04
Decision date: 1983-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.