SABRATEK PATIENT HOME MANAGEMENT SYSTEM— 510(k) K980619

Substantially Equivalent

Sabratek Corp.

FDA 510(k) clearance K980619 for SABRATEK PATIENT HOME MANAGEMENT SYSTEM, Substantially Equivalent on 1998-08-20. Applicant: Sabratek Corp..

Clearance details

Applicant: Sabratek Corp.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 1998-02-18
Decision date: 1998-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.