| Device Type ID | 3999 |
| Device Name | Monitor, Ultrasonic, Fetal |
| Regulation Description | Fetal Ultrasonic Monitor And Accessories. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.2660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KNG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3999 |
| Device | Monitor, Ultrasonic, Fetal |
| Product Code | KNG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fetal Ultrasonic Monitor And Accessories. |
| CFR Regulation Number | 884.2660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EDAN INSTRUMENTS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDAN INSTRUMENTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | Mar-19-2018 |