510(k) K071164
- Device
- LIFE+CEL BATTERY
- Applicant
- AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
- 510(k) number
- K071164
- Product code
- MOY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-07
- Date received
- 2007-04-26
- Regulation
- 510(k) Premarket Notification
- Classification name
- Batteries, Rechargeable, For Class 3 Devices
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALEX HENDERSON
- Address
- 377 Zane Ct. Hillside Village Elizabeth CO US 80107 80107
FDA Registration Numbers#
- 8022257
- 3012421607
- 3009490946
- 3003263092
- 3003832357
- 3030446844
- 3012307300
- 3021219789
- 3007048291
- 1651104
- 1219324
- 3012528160
- 8030229
- 3013501110
- 3010611950
- 3008363989
- 3005783425
- 1054713
- 3004035727
- 3009156722
- 3013314298
- 3006979678
- 3007836437
- 3016701404
- 3004977335
- 3008483389
- 3013500228
- 2032233
- 3004196561
- 3014579161
- 3018783526
- 3006087789
- 3006147705
- 3007603826
- 3008058135
- 3010536822
- 3000126629
- 3007734888
- 3009831876
- 3032109181
- 3014848734
- 3007305624
- 3016852448
- 3010882708
- 3008255748
- 3023272766
- 2221819
- 3015997711
- 3030597679
- 1000484830
- 3005906887
- 9610816
- 3016931915
- 3012359877
- 3016674095
- 3014633893
- 3005877899
- 3008716327
- 3000162901
- 1000122786
- 3010390468
- 3014263632
- 3008729547
- 3013679558
- 3009715978
- 3015328411
- 3020115
- 1218950
- 3009973336
- 3001104093
- 3009077524
- 3013557562
- 3009673645
- 3010552191
- 9611500
- 1316463
- 3030516450
- 9610105
- 3022123357
- 3019388613
Source Documents#
Legacy Summary#
summary
FDA Review#
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