ELECTROMEDICS BLOOD HEAT EXCHANGER— 510(k) K934355

Substantially Equivalent

Electromedics, Inc.

FDA 510(k) clearance K934355 for ELECTROMEDICS BLOOD HEAT EXCHANGER, Substantially Equivalent on 1993-12-03. Applicant: Electromedics, Inc..

Clearance details

Applicant: Electromedics, Inc.
Product code: 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

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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.