RHYTHM OF LIFE, MODEL R0901-05— 510(k) K092408

Name: FDA 510(k) clearance K092408
Creator: U.S. Food and Drug Administration
Published: 2009-10-14

Substantially Equivalent

Rapid Response Solutions, LLC

FDA 510(k) clearance K092408 for RHYTHM OF LIFE, MODEL R0901-05, Substantially Equivalent on 2009-10-14. Applicant: Rapid Response Solutions, LLC. Device class: 2.

Clearance details

Applicant: Rapid Response Solutions, LLC
Product code: Code LIX
Device class: Class 2
Regulation: 21 CFR 870.5210
Advisory panel: Cardiovascular
Date received: 2009-08-06
Decision date: 2009-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LIX

product code LIX

Other: 2
Total: 2

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.