The following data is part of a premarket notification filed by Ameda, Inc. with the FDA for Mya Joy Plus Breast Pump.
| Device ID | K203570 |
| 510k Number | K203570 |
| Device Name: | Mya Joy PLUS Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Ameda, Inc. 485 Half Day Road; Suite 320 Buffalo Grove, IL 60089 |
| Contact | Carolin Archibald |
| Correspondent | Sean Gm Pettibone Ameda, Inc. 485 Half Day Road; Suite 320 Buffalo Grove, IL 60089 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810725025772 | K203570 | 000 |
| 00810725025598 | K203570 | 000 |
| 00810725025581 | K203570 | 000 |
| 00810725025574 | K203570 | 000 |