Sometimes, the cardiac monitor acts only as a signal acquisition device, and transmits via radio frequency telemetry (or hardwire) the detected ECG waveforms to a central station for processing. Note that this guidance does not apply to the following cardiac monitors, which are classified elsewhere, and excluded by the EC13 standard: Included in the EC13 standard are ECG devices intended for monitoring purposes diagnostic ECG devices are addressed by EC11, and are discussed in further detail in the FDA guidance 'Diagnostic ECG Devices.' This guidance applies to most of the cardiac monitors covered by the ANSI/AAMI EC13-1992 standard for Cardiac Monitors, Heart Rate Meters, and Alarms (EC13 standard). This guidance is intended to aid in the preparation or review of premarket notification (510(k)) applications for the devices regulated under:Ģ1 CFR §870.2300, Cardiac Monitor (including cardiotachometer and rate alarm) An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. It represents the Agency's current thinking on the above. Cardiac Monitor Guidance 1ġThis document is intended to provide guidance. Please use the document number 2233 to identify the guidance you are requesting. You may also send an e-mail request to to receive a copy of the guidance. For questions regarding the use or interpretation of this guidance contact James Cheng at 24 or e-mail at Additional CopiesĪdditional copies are available from the Internet. Comments may not be acted upon by the Agency until the document is next revised or updated.

Department Of Health And Human Servicesĭivision of Cardiovascular and Respiratory DevicesĬomments and suggestions may be submitted at any time for Agency consideration to James Cheng, Center for Devices and Radiological Health, 9200 Corporate Boulevard, HFZ-450, Rockville, MD 20850. Center for Devices and Radiological Health

Hospital heart monitor