DeviceClearance

Pression Wave PRO External Counter-Pulsation System— 510(k) K250756

Substantially Equivalent

Pression, Inc.

FDA 510(k) clearance K250756 for Pression Wave PRO External Counter-Pulsation System, Substantially Equivalent on 2025-12-22. Applicant: Pression, Inc..

Clearance details

Applicant
Pression, Inc.
Product code
Code DRN
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Coatesville, PA, US
Download summary PDFView on FDA.gov ↗

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