EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
FDA 510(k) clearance K080587 · decided 2008-05-15
Clearance details
- K-number
- K080587
- Device name
- EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
- Applicant
- Animas Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-03
- Decision date
- 2008-05-15
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- MRZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
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|---|---|---|
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PMA approvals by this applicant
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|---|---|---|
| Animas Vibe System (P130007/S036) | Animas Corp. | 2018-07-11 |
| Animas Vibe System (P130007/S035) | Animas Corp. | 2018-04-18 |
| Animas Vibe System (P130007/S034) | Animas Corp. | 2018-03-12 |
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| Animas Vibe System (P130007/S031) | Animas Corp. | 2017-10-24 |
| Animas Vibe System (P130007/S029) | Animas Corp. | 2017-08-17 |
| Animas, Vibe System (P130007/S026) | Animas Corp. | 2017-06-09 |