| Device Type ID | 3960 |
| Device Name | Pump, Breast, Non-powered |
| Regulation Description | Nonpowered Breast Pump. |
| 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) Exempt |
| CFR Regulation Number | 884.5150 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HGY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3960 |
| Device | Pump, Breast, Non-powered |
| Product Code | HGY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonpowered Breast Pump. |
| CFR Regulation Number | 884.5150 [🔎] |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 5 |
Device Operates Differently Than Expected | 3 |
Patient-Device Incompatibility | 2 |
Suction Problem | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Fitting Problem | 2 |
Decrease In Suction | 1 |
Insufficient Information | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ameda, Inc. | II | Mar-26-2015 |