Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K990338 |
Device Name |
NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM |
Applicant |
PHYSIO-CONTROL CORP. |
11811 WILLOWS RD. N.E. |
P.O. BOX 97006 |
REDMOND,
WA
98073 -9706
|
|
Applicant Contact |
BOB ZITO |
Correspondent |
PHYSIO-CONTROL CORP. |
11811 WILLOWS RD. N.E. |
P.O. BOX 97006 |
REDMOND,
WA
98073 -9706
|
|
Correspondent Contact |
BOB ZITO |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 02/03/1999 |
Decision Date | 09/01/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|