WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM— 510(k) K112370
Substantially EquivalentWelldoc, Inc.
FDA 510(k) clearance K112370 for WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM, Substantially Equivalent on 2011-10-14. Applicant: Welldoc, Inc.. Device class: 2.
Clearance details
- Applicant
- Welldoc, Inc.
- Product code
- Code MRZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Baltimore, MD, US
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