INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0— 510(k) K062068

Substantially Equivalent

Intelwave, LLC

FDA 510(k) clearance K062068 for INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0, Substantially Equivalent on 2006-10-27. Applicant: Intelwave, LLC.

Clearance details

Applicant: Intelwave, LLC
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2006-07-21
Decision date: 2006-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.