Pure Flow External Counter-Pulsation Device— 510(k) K173483
Substantially EquivalentXtreem Pulse, LLC
FDA 510(k) clearance K173483 for Pure Flow External Counter-Pulsation Device, Substantially Equivalent on 2018-05-30. Applicant: Xtreem Pulse, LLC.
Clearance details
- Applicant
- Xtreem Pulse, LLC
- Product code
- Code DRN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.