Ameda Hand Breast Pump
FDA 510(k) K823591 · Burditt & Calkins-Siemens-Elema
510(k) numberK823591
Submission
- Device name
- Ameda Hand Breast Pump
- Applicant
- Burditt & Calkins-Siemens-Elema
Mchenry, IL, US - Received
- December 6, 1982
- Decision date
- December 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGY – Pump, Breast, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5150
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101538 | Handheld Manual Breast Pump (Avent Manual Breast Pump)HGY · Traditional | Philips Electronics UK Limited | 11/05/2010SE |
| K032845 | Easy Comfort Deluxe Manual Breast Pump, Model 1187HGY · Traditional | The First Years, Inc. | 04/05/2004SE |
| K013226 | Evenflo Comfort Ease Manual Breast Pump KitHGY · Traditional | Evenflo Company, Inc. | 12/20/2001SE |
| K011519 | Ameda HygienikitHGY · Traditional | Hollister, Inc. | 08/15/2001SE |
| K971231 | White River Mini Manual Breast PumpHGY · Traditional | White River Concepts | 05/19/1997SE |
| K962828 | Evert-ItHGY · Traditional | Genesis Industries, Inc. | 02/10/1997SE |
| K952034 | Medela's Foot PumpHGY · Traditional | Medela, Inc. | 09/12/1995SE |
| K952035 | NipletteHGY · Traditional | Avent America, Inc. | 07/28/1995SE |
| K925738 | White River Manual Breast PumpHGY · Traditional | White River (Tm) | 05/04/1994SE |
| K912355 | Mothers Touch One Hand Breast PumpHGY · Traditional | Hollister, Inc. | 12/10/1993SE |
More from Hollister, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833519 | Pulse Generator Model 688DXY · Traditional | 01/30/1984SE |
| K833155 | Rayden Medical Mini Pulse Volume RecordDSB · Traditional | 01/26/1984SE |
| K830344 | Siemens-Elma Pulse Generator #718DXY · Traditional | 05/27/1983SE |
| K823435 | Mon-A-Therm Myocardial Temp. SensorKRB · Traditional | 12/30/1982SE |
| K822239 | Coaxial Bipolar Pacing ElectrodeDTB · Traditional | 10/04/1982SE |
| K821712 | Informed Remote Field Unit Model IFM1000BTY · Traditional | 07/26/1982SE |
| K803111 | ErectaidFAE · Traditional | 01/23/1981SE |
| K802607 | Terperatur Sensing DeviceFLL · Traditional | 11/19/1980SE |
| K760787 | Liberator/StrollerBYJ · Traditional | 10/22/1976SE |
Questions and answers
When was Ameda Hand Breast Pump cleared by the FDA?
Ameda Hand Breast Pump (K823591) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 22 days after the submission was received.
What is the product code of K823591?
The FDA product code is HGY – Pump, Breast, Non-Powered, a Class I (low risk) device regulated under 21 CFR 884.5150.