EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR— 510(k) K991293

Name: FDA 510(k) clearance K991293
Creator: U.S. Food and Drug Administration
Published: 2000-05-05

Substantially Equivalent

Fischer Medical Technologies, Inc.

FDA 510(k) clearance K991293 for EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR, Substantially Equivalent on 2000-05-05. Applicant: Fischer Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Fischer Medical Technologies, Inc.
Product code: Code JOQ
Device class: Class 2
Regulation: 21 CFR 870.1750
Advisory panel: Cardiovascular
Date received: 1999-04-15
Decision date: 2000-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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