CARE TELSTAT MODELS: MP 5010 AND MP 5020— 510(k) K874844

Substantially Equivalent

Care Systems, Inc.

FDA 510(k) clearance K874844 for CARE TELSTAT MODELS: MP 5010 AND MP 5020, Substantially Equivalent on 1988-02-09. Applicant: Care Systems, Inc..

Clearance details

Applicant: Care Systems, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1987-11-24
Decision date: 1988-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntsville, AL, 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.