The following data is part of a premarket notification filed by Amsino International Inc. with the FDA for Amsure Enteral Feeding Pump.
Device ID | K220230 |
510k Number | K220230 |
Device Name: | AMSure Enteral Feeding Pump |
Classification | Pump, Infusion, Enteral |
Applicant | Amsino International Inc. 708 Corporate Center Drive Pomona, CA 91768 |
Contact | Jane Gao |
Correspondent | Jane Gao Amsino International Inc. 708 Corporate Center Drive Pomona, CA 91768 |
Product Code | LZH |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-27 |
Decision Date | 2022-11-10 |