The following data is part of a premarket notification filed by Shift Labs, Inc. with the FDA for Dripassist Plus.
Device ID | K172242 |
510k Number | K172242 |
Device Name: | DripAssist Plus |
Classification | Monitor, Electric For Gravity Flow Infusion Systems |
Applicant | Shift Labs, Inc. 1600 Dexter Ave N, Suite A Seattle, WA 98109 |
Contact | Beth Kolko |
Correspondent | Camelia Kouki Shift Labs, Inc. 1600 Dexter Ave N, Suite A Seattle, WA 98109 |
Product Code | FLN |
CFR Regulation Number | 880.2420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-26 |
Decision Date | 2018-05-25 |
Summary: | summary |