FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WellDoc BlueStar
K Number: K190013
·
Decision Nov 4, 2019
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
47
Applicant Total
11
Review Days
305
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Basic Information
- Device Name
- WellDoc BlueStar
- K Number
- K190013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welldoc, Inc.
- Date Received
- January 3, 2019
- Decision Date
- November 4, 2019
- Product Code
- MRZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | FDA class 2 | General Hospital |
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|---|---|---|---|
| K222888 | BlueStar CGM insulin dose calculator | Aug 11, 2023 | Substantially Equivalent |
| K230813 | BlueStar and BlueStar Rx | Jul 28, 2023 | Substantially Equivalent |
| K203434 | BlueStar Rx | Sep 8, 2021 | Substantially Equivalent |
| K193654 | BlueStar Rx | Apr 7, 2020 | Substantially Equivalent |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Jan 12, 2017 | Substantially Equivalent |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | Nov 22, 2016 | Substantially Equivalent |
| K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | Jul 8, 2014 | Substantially Equivalent |
| K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Feb 24, 2012 | Substantially Equivalent |
| K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Oct 14, 2011 | Substantially Equivalent |
| K100066 | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 | Jul 15, 2010 | Substantially Equivalent |