OMNIPOD INSULIN MANAGMENT SYSTEM
FDA 510(k) clearance K122953 · decided 2012-12-07
Clearance details
- K-number
- K122953
- Device name
- OMNIPOD INSULIN MANAGMENT SYSTEM
- Applicant
- Insulet Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-09-25
- Decision date
- 2012-12-07
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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