FDA 510(k) K903136, ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER, by Arzco Medical Electronics, Inc.
FDA 510(k) K903136, ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER, by Arzco Medical Electronics, Inc.
Device Classification Name: Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number: K903136
Device Name: ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER
Applicant: Arzco Medical Electronics, Inc.
Regulation Number: 870.1220
Classification Product Code: DRF
Date Received: 07/17/1990
Decision Date: 01/18/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total number of pages: 125
Fully redacted pages: 49
Content pages: 76
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