Atlas FDA

EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE

FDA 510(k) clearance K063674 · decided 2007-03-30

Clearance details

K-number
K063674
Device name
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
Applicant
Animas Corp.
Decision
Substantially Equivalent
Date received
2006-12-11
Decision date
2007-03-30
Days to decision
109 days
Clearance type
Traditional
Product code
LZG
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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
Animas Vibe System (P130007/S033)Animas Corp.2018-03-01
Animas Vibe System (P130007/S027)Animas Corp.2017-10-27
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