FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
K Number: K141273
·
Decision Jul 8, 2014
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
47
Applicant Total
11
Review Days
53
Basic Information
- Device Name
- WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
- K Number
- K141273
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welldoc, Inc.
- Date Received
- May 16, 2014
- Decision Date
- July 8, 2014
- 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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