FDA 510(k) K904943, TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE, by Arzco Medical Electronics, Inc.
FDA 510(k) K904943, TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE, by Arzco Medical Electronics, Inc.
Device Classification Name: Stethoscope, Esophageal, With Electrical Conductors
510(k) Number: K904943
Device Name: TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
Applicant: Arzco Medical Electronics, Inc.
Regulation Number: 868.1920
Classification Product Code: BZT
Date Received: 11/01/1990
Decision Date: 04/26/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
510k Review Panel: Anesthesiology
Total number of pages: 392
Fully redacted pages: 292
Content pages: 100
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details