FDA-Device2019-06-19Class III
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entran
Cardiocommand Inc.
Hazard
Possible corrosion of the battery contact(s).
Sold states
US Nationwide distribution in the states of CT, VW, OH, IL, DE.
Affected count
5 units
Manufactured in
4920 W Cypress St Ste 110, N/A, Tampa, FL, United States
Products
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1773-2019Don't want to check this manually?
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