New Mother's Way-Breast Pump
FDA 510(k) K834399 · Huntleigh Technology, Inc.
510(k) numberK834399
Submission
- Device name
- New Mother's Way-Breast Pump
- Applicant
- Huntleigh Technology, Inc.
Mchenry, IL, US - Received
- December 14, 1983
- Decision date
- January 17, 1984
- 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 |
|---|---|---|
| K992733 | Akron ATP9 Traction MachineITH · Traditional | 11/10/1999SE |
| K964699 | Rheo Dopplex II (RD 2)IYN · Traditional | 02/21/1997SE |
| K924516 | OP3/VP4HGL · Traditional | 06/28/1993SE |
| K910188 | Flowplus AC330 Pump GarmentsJOW · Traditional | 05/28/1991SE |
| K900882 | Multi Dopplex, MD-1JAF · Traditional | 08/22/1990SE |
| K900618 | Huntleigh Fetal Doppler, FD-1 & Dopcord, D140KNG · Traditional | 04/25/1990SE |
| K890012 | Huntleigh Dynamic Flotation SystemFNM · Traditional | 03/29/1989SE |
| K884451 | Dopcord PPGJOM · Traditional | 01/12/1989SE |
| K881632 | Flowtron DVT System AC500 Pump, L501 GarmentJOW · Traditional | 09/26/1988SE |
| K874688 | Flowtron AC200/2IRP · Traditional | 09/23/1988SE |
Questions and answers
When was New Mother's Way-Breast Pump cleared by the FDA?
New Mother's Way-Breast Pump (K834399) received a 510(k) decision of Substantially Equivalent on January 17, 1984, 34 days after the submission was received.
What is the product code of K834399?
The FDA product code is HGY – Pump, Breast, Non-Powered, a Class I (low risk) device regulated under 21 CFR 884.5150.