HEAT EXCHANGER, FHX-14— 510(k) K781210

Substantially Equivalent

Delta Medical Industries

FDA 510(k) clearance K781210 for HEAT EXCHANGER, FHX-14, Substantially Equivalent on 1978-10-10. Applicant: Delta Medical Industries.

Clearance details

Applicant: Delta Medical Industries
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1978-07-17
Decision date: 1978-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.