Device Type ID | 79 |
Device Name | Stethoscope, Esophageal |
Regulation Description | Esophageal Stethoscope. |
Regulation Medical Specialty | Anesthesiology |
Review Panel | Anesthesiology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 868.1910 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | BZW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 79 |
Device | Stethoscope, Esophageal |
Product Code | BZW |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Esophageal Stethoscope. |
CFR Regulation Number | 868.1910 [🔎] |