TELESENTRY, MODEL TS01— 510(k) K092947

Substantially Equivalent

Scottcare Corporation

FDA 510(k) clearance K092947 for TELESENTRY, MODEL TS01, Substantially Equivalent on 2010-02-26. Applicant: Scottcare Corporation.

Clearance details

Applicant: Scottcare Corporation
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2009-09-24
Decision date: 2010-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.