| Device Type ID | 3956 |
| Device Name | Electrode, Circular (spiral), Scalp And Applicator |
| Regulation Description | Fetal Scalp Circular (spiral) Electrode And Applicator. |
| 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 | 884.2675 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HGP |
| 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 | 3956 |
| Device | Electrode, Circular (spiral), Scalp And Applicator |
| Product Code | HGP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fetal Scalp Circular (spiral) Electrode And Applicator. |
| CFR Regulation Number | 884.2675 [🔎] |
| Device Problems | |
|---|---|
Failure To Read Input Signal | 9 |
Human Factors Issue | 5 |
Material Fragmentation | 4 |
Failure To Disconnect | 4 |
Device Operates Differently Than Expected | 4 |
Difficult To Remove | 2 |
Electrode | 1 |
Entrapment Of Device | 1 |
Break | 1 |
Shelf Life Exceeded | 1 |
Patient Device Interaction Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
| Total Device Problems | 34 |