EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR

Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)

FISCHER MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Fischer Medical Technologies, Inc. with the FDA for Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215 Electrophysiology Programmable Stimulator.

Pre-market Notification Details

• Device ID: K991293
• 510k Number: K991293
• Device Name: EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
• Classification: Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)
• Applicant: FISCHER MEDICAL TECHNOLOGIES, INC. 12300 NORTH GRANT Denver, CO 80241
• Contact: Ronald Shores
• Correspondent: Ronald Shores; FISCHER MEDICAL TECHNOLOGIES, INC. 12300 NORTH GRANT Denver, CO 80241
• Product Code: JOQ
• CFR Regulation Number: 870.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-15
• Decision Date: 2000-05-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00863019000320	K991293	000
00863019000313	K991293	000
00863019000306	K991293	000