Atlas FDA

LIFE+CEL BATTERY

FDA 510(k) clearance K071164 · decided 2007-12-07

Clearance details

K-number
K071164
Device name
LIFE+CEL BATTERY
Applicant
Amco International Manufacturing & Design, Inc.
Decision
Substantially Equivalent
Date received
2007-04-26
Decision date
2007-12-07
Days to decision
225 days
Clearance type
Traditional
Product code
MHX
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Elizabeth, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.