Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K071164 |
Device Name |
LIFE+CEL BATTERY |
Applicant |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
377 ZANE COURT |
HILLSIDE VILLAGE |
ELIZABETH,
CO
80107
|
|
Applicant Contact |
ALEX HENDERSON |
Correspondent |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
377 ZANE COURT |
HILLSIDE VILLAGE |
ELIZABETH,
CO
80107
|
|
Correspondent Contact |
ALEX HENDERSON |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 04/26/2007 |
Decision Date | 12/07/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|