Reprocessed Halo XP Diagnostic Electrophysiology Catheter— 510(k) K171788

Substantially Equivalent

Innovative Health, LLC

FDA 510(k) clearance K171788 for Reprocessed Halo XP Diagnostic Electrophysiology Catheter, Substantially Equivalent on 2017-11-03. Applicant: Innovative Health, LLC.

Clearance details

Applicant
Innovative Health, LLC
Product code
Code NLH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Scottsdale, AZ, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.