510(k) K973501 ยท HGX Pump, Breast, Powered
EXPRESSE AND PREMIER POWERED BREAST PUMPS
| Applicant | Ameda Medizintechnik AG, Libertyville IL, US |
| Decision | Substantially Equivalent, Dec 11, 1997 |
| Received | Sep 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973501
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2017 | AMEDA, INC. Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA.
Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a Open, Classified |
HGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.