ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)— 510(k) K103643

Name: FDA 510(k) clearance K103643
Creator: U.S. Food and Drug Administration
Published: 2011-10-06

Substantially Equivalent

Ascot Technologies, Inc.

FDA 510(k) clearance K103643 for ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS), Substantially Equivalent on 2011-10-06. Applicant: Ascot Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ascot Technologies, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2010-12-13
Decision date: 2011-10-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Cary, NC, US

Download summary PDF View on FDA.gov ↗

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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.