Device Type ID | 5268 |
Device Name | Monitor, Fetal Doppler Ultrasound |
Regulation Description | Fetal Ultrasonic Monitor And Accessories. |
Regulation Medical Specialty | Obstetrics/Gynecology |
Review Panel | Radiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 884.2660 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MAA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |