K181497

Substantially Equivalent

HPM-6000UF

Applicant: BTL Industries, Inc.
Product code: KPI
Advisory panel: Gastroenterology, Urology
Date received: 2018-06-07
Decision date: 2018-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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