AMEDA HAND BREAST PUMP
FDA 510(k) clearance K823591 · decided 1982-12-28
Clearance details
- K-number
- K823591
- Device name
- AMEDA HAND BREAST PUMP
- Applicant
- Burditt & Calkins-Siemens-Elema
- Decision
- Substantially Equivalent
- Date received
- 1982-12-06
- Decision date
- 1982-12-28
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- HGY
- Device class
- 1
- Regulation number
- 884.5150
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (K101538) | Philips Electronics UK Limited | 2010-11-05 |
| EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (K032845) | The First Years, Inc. | 2004-04-05 |
| EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (K013226) | Evenflo Company, Inc. | 2001-12-20 |
| AMEDA HYGIENIKIT (K011519) | Hollister, Inc. | 2001-08-15 |
| WHITE RIVER MINI MANUAL BREAST PUMP (K971231) | White River Concepts | 1997-05-19 |
| EVERT-IT (K962828) | Genesis Industries, Inc. | 1997-02-10 |
| MEDELA'S FOOT PUMP (K952034) | Medela, Inc. | 1995-09-12 |
| NIPLETTE (K952035) | Avent America, Inc. | 1995-07-28 |
| WHITE RIVER MANUAL BREAST PUMP (K925738) | White River (Tm) | 1994-05-04 |
| MOTHERS TOUCH ONE HAND BREAST PUMP (K912355) | Hollister, Inc. | 1993-12-10 |
| GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (K902552) | Gerber Products Co. | 1990-09-26 |
| CRYSTAL MANUAL BREAST PUMP (K850242) | Crystal Medical Products, Inc. | 1985-02-25 |
Recalls involving this device
No recalls on record reference this clearance.