FDA.reportPublic FDA data

510(k) K072596

Device
LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
Applicant
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
510(k) number
K072596
Product code
MOY  
Decision
Substantially Equivalent (SESE)
Decision date
2008-01-24
Date received
2007-09-14
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
3
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ALEXANDER B HENDERSON
Address
377 Zane Ct. Elizabeth CO US 80107 80107

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases