Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K133659 |
Device Name |
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING |
Applicant |
PHILIPS MEDICAL SYSTEMS |
22100 BOTHELL EVERETT WAY |
BOTHELL,
WA
98021
|
|
Applicant Contact |
JOHN PARDO |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
22100 BOTHELL EVERETT WAY |
BOTHELL,
WA
98021
|
|
Correspondent Contact |
CARLENE COMRIE |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/27/2013 |
Decision Date | 01/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|