Devices · WellDoc, Inc.

WellDoc BlueStar

WellDoc, Inc. is listed for WellDoc BlueStar (K190013). The FDA list gives November 4, 2019 as the date of the final decision. The lead panel is General Hospital, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MRZ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190013

Official FDA database record

Date of final decision

November 4, 2019

Company on the FDA list

WellDoc, Inc.

Lead panel

General Hospital

Primary product code

MRZ

openFDA device name for the code

Accessories, Pump, Infusion

Device class

2

Regulation number

880.5725

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary