STONY BROOK MODEL EECP-MC1— 510(k) K882401

Name: FDA 510(k) clearance K882401
Creator: U.S. Food and Drug Administration
Published: 1989-03-03

Substantially Equivalent

Stony Brook Trading and Development Corp.

FDA 510(k) clearance K882401 for STONY BROOK MODEL EECP-MC1, Substantially Equivalent on 1989-03-03. Applicant: Stony Brook Trading and Development Corp.. Device class: 2.

Clearance details

Applicant: Stony Brook Trading and Development Corp.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 1988-06-10
Decision date: 1989-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northport, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRN

view all

K250756 — Pression Wave PRO External Counter-Pulsation System2025-12-22
K202108 — External Counterpulsation System, Soulaire2020-08-28
K191955 — Enhanced External Counter Pulsation Device Plus Omay-A2020-08-05
K190683 — External Counterpulsation System2019-09-10
K173483 — Pure Flow External Counter-Pulsation Device2018-05-30

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