FDA.report

510(k) K250756

Device
Pression Wave PRO External Counter-Pulsation System
Applicant
Pression, Inc.
510(k) number
K250756
Product code
DRN
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-22
Date received
2025-03-12
Regulation
870.5225
Classification name
Device, Counter-Pulsating, External
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Adam Salamon
Address
190 W. Lincoln Hwy. Coatesville PA US 19320 19320

FDA Registration Numbers

Source Documents

510(k) summary PDF

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