K934355

Substantially Equivalent

ELECTROMEDICS BLOOD HEAT EXCHANGER

Applicant: Electromedics, Inc.
Product code: DTR
Advisory panel: Cardiovascular
Date received: 1993-09-07
Decision date: 1993-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.