Skip to content

Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215 Electrophysiology Programmable Stimulator

by Fischer Medical Technologies, Inc.

510(k) K991293

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991293 Date5 May 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0713-05 FDA Unclassified (pre-2012) initiated 13 Jan 2005

    Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JOQ
Device Class
Class II
Regulation
21 CFR Part 870.1750
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent