The following data is part of a premarket notification filed by Shift Labs with the FDA for Dripassist.
Device ID | K150687 |
510k Number | K150687 |
Device Name: | DripAssist |
Classification | Monitor, Electric For Gravity Flow Infusion Systems |
Applicant | Shift Labs 1752 NW Market St.#211 Seattle, WA 98107 |
Contact | Beth Kolko |
Correspondent | Steven Chernoff DRUG AND DEVICE DEVELOPMENT CO., INC. P.O.BOX 3515 Redmond, WA 98073 |
Product Code | FLN |
CFR Regulation Number | 880.2420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-17 |
Decision Date | 2015-10-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DRIPASSIST 88088198 5714890 Live/Registered |
Shift Labs Inc. 2018-08-22 |