WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
FDA 510(k) clearance K141273 · decided 2014-07-08
Clearance details
- K-number
- K141273
- Device name
- WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
- Applicant
- Welldoc, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-16
- Decision date
- 2014-07-08
- Days to decision
- 53 days
- Clearance type
- Special
- Product code
- MRZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Baltimore, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.