SINGLE PATIENT SYS. II MODEL DM-450— 510(k) K832053

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K832053 for SINGLE PATIENT SYS. II MODEL DM-450, Substantially Equivalent on 1983-09-29. Applicant: Extracorporeal Medical Specialities, Inc..

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1983-06-27
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.