TelePatch Cardiac Monitor— 510(k) K161916

Substantially Equivalent

Medicomp, Inc.

FDA 510(k) clearance K161916 for TelePatch Cardiac Monitor, Substantially Equivalent on 2016-12-21. Applicant: Medicomp, Inc..

Clearance details

Applicant: Medicomp, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2016-07-12
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.