Reprocessed Response Diagnostic Electrophysiology Catheters— 510(k) K161827
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K161827 for Reprocessed Response Diagnostic Electrophysiology Catheters, Substantially Equivalent on 2016-12-08. Applicant: Innovative Health, LLC. Device class: 2.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Code NLH
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.