Stethoscope, Esophageal

Device Code: 79

Product Code(s): BZW

Device Classification Information

Device Type ID79
Device NameStethoscope, Esophageal
Regulation DescriptionEsophageal Stethoscope.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(K) Exempt
CFR Regulation Number868.1910 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBZW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID79
DeviceStethoscope, Esophageal
Product CodeBZW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEsophageal Stethoscope.
CFR Regulation Number868.1910 [🔎]
TPLC Last Update: 2019-04-02 19:27:58

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.