FDA 510(k) K905831, ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH, by Arzco Medical Electronics, Inc.
FDA 510(k) K905831, ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH, by Arzco Medical Electronics, Inc.
Device Classification Name: Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number: K905831
Device Name: ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH
Applicant: Arzco Medical Electronics, Inc.
Regulation Number: 870.1220
Classification Product Code: DRF
Date Received: 12/31/1990
Decision Date: 03/29/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total number of pages: 143
Fully redacted pages: 64
Content pages: 79
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