The following data is part of a premarket notification filed by Ameda, Inc. with the FDA for Ameda Pearl Electric Breast Pump.
| Device ID | K221576 |
| 510k Number | K221576 |
| Device Name: | Ameda Pearl Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Ameda, Inc. 485 Half Day Road; Suite 320 Buffalo Grove, IL 60089 |
| Contact | Sean Pettibone |
| Correspondent | Sean 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 | 2022-06-01 |
| Decision Date | 2022-10-12 |