SIEMENS-ELEMA AB AGA REVIVATOR— 510(k) K822213

Substantially Equivalent

Siemens Elema AB

FDA 510(k) clearance K822213 for SIEMENS-ELEMA AB AGA REVIVATOR, Substantially Equivalent on 1982-10-28. Applicant: Siemens Elema AB.

Clearance details

Applicant: Siemens Elema AB
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1982-07-26
Decision date: 1982-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.