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Bci Mini-Torr Plus, Model 6004

by Bci Intl., Inc. 510(k)

Active United States

510(k) K984618

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984618 Date25 Mar 1999ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1649-2008 FDA Unclassified (pre-2012) initiated 2 Apr 2008

    Due to a component that may be installed backwards, the device may turn off or may immediately reset.

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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