| Device Type ID | 3934 |
| Device Name | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Regulation Description | External Uterine Contraction 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 | 884.2720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HFM |
| 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 | 3934 |
| Device | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Product Code | HFM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Uterine Contraction Monitor And Accessories. |
| CFR Regulation Number | 884.2720 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARGON MEDICAL DEVICES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CLINICAL INNOVATIONS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |