Device Type ID | 731 |
Device Name | Stethoscope, Electronic |
Regulation Description | Stethoscope. |
Regulation Medical Specialty | Cardiovascular |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
Submission Type | 510(k) |
CFR Regulation Number | 870.1875 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DQD |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 731 |
Device | Stethoscope, Electronic |
Product Code | DQD |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Stethoscope. |
CFR Regulation Number | 870.1875 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
AMERICAN DIAGNOSTIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AUM CARDIOVASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EKO DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
IMEDIPLUS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 |