KELLER CARDIAC MONITOR MEDIL KMS870— 510(k) K914576

Substantially Equivalent

Keller Medical Specialties Products, Inc.

FDA 510(k) clearance K914576 for KELLER CARDIAC MONITOR MEDIL KMS870, Substantially Equivalent on 1991-12-30. Applicant: Keller Medical Specialties Products, Inc..

Clearance details

Applicant: Keller Medical Specialties Products, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1991-10-15
Decision date: 1991-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antioch, IL, US

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Adverse events under product code DRT

product code DRT

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.