Product code JOQ— Cardiovascular
Bloom2 Programmable Electrophysiology Stimulator
- Classification name
- Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- Device class
- Class 2
- Regulation
- 21 CFR 870.1750
- Advisory panel
- Cardiovascular
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code JOQ
FDA has cleared devices under product code JOQ between 1984 and 2018, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2009
- 2007
- 2004
- 2002
- 2000
- 1996
- 1994
- 1990
- 1989
- 1986
- 1985
- 1984
Top applicants under product code JOQ
Recent clearances under product code JOQ
- K173439 — Bloom2 Programmable Electrophysiology Stimulator
- K092913 — EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
- K072200 — STIMLAB
- K070743 — Z6 STIMULATOR
- K041442 — EP-4 CLINICAL STIMUTATOR
- K040207 — EP-4 CLINICAL STIMULATOR
- K011826 — EPS320 CARDIAC STIMULATOR
- K991293 — EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
- K963579 — PACE-1A CARDIAC STIMULATOR
- K935590 — EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR
- K900553 — CONSTANT CURRENT STIMULATOR MODEL 022101
- K893094 — HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM
- K861368 — MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
- K852746 — EXTERNAL PACEMAKER TELECTRONICS TE200
- K844815 — CORDIS ELECTROPHYSIOLOGY STIMULATOR
- K851091 — MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
- K843718 — PROGRAMMABLE STIMULATOR 5326
- K833421 — PROGRAMMABLE STIMULATOR 2352
Data sourced from openFDA. This site is unofficial and independent of the FDA.