Paceart Optima System Software

510(k) Number

K110693 ↗

FDA product code

KRE

Device class

Class II

Regulation

21 CFR Part 870.3640

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code KRE (Analyzer, Pacemaker Generator Function, Indirect).

• EKG SPEAKS by MEDTRONIC VASCULAR, INC.
• PACEMAKER SYS ANALYZER #384 by Pacesetter Systems
• Ultra-Chek Pacemaker Monitor by Powers Medical Systmes
• ELECTRONIC PACEMAKER WAVEFORM ANALYZER by Instromedix, Inc.
• PACEART CPTS-86/12 by Paceart, Inc.
• CYGNUS 12 LEAD ECG MODULE by Cygnus, LLC
• PACEMAKER SYS. ANALYZER 378 by Siemens Elema AB
• HPM 40 HEART PACEMAKER MONITOR by Biotronik, Inc.
• CARDIOMEMO by Instromedix, Inc.
• PACEMAKER FUNCTION ANALYZER by Paceart, Inc.

• BB11A61R10

  Class II

  FDA 510(k) K171979 Active Cleared 27 Oct 2017 GUDID on market

• CapSureFix™ Novus

  Class III

  CE/MDR

• Rf Marinr™

  Class III

  CE/MDD

• Achieve™

  Class III

  CE/MDD

See all devices from Medtronic, Inc. →