|
Device | LIFEPAK® 20e defibrillator/monitor |
Generic Name | automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant |
Physio-Control. Inc. |
11811 willows road ne |
redmond, WA 98052 |
|
PMA Number | P160026 |
Supplement Number | S006 |
Date Received | 04/11/2019 |
Decision Date | 05/09/2019 |
Product Code |
MKJ
|
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Manufacturing process change that impacts the pulse oximetry (Sp02) module component of the LIFEPAK 20e defibrillator/monitor. |