Device Classification Name |
Detector And Alarm, Arrhythmia
|
510(k) Number |
K050605 |
Device Name |
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 |
Applicant |
SPACELABS MEDICAL INC. |
5150 220TH AVE SE |
PO BOX 7018 |
ISSAQUAH, WA,
WA
98027 -7018
|
|
Applicant Contact |
AL VAN HOUDT |
Correspondent |
SPACELABS MEDICAL INC. |
5150 220TH AVE SE |
PO BOX 7018 |
ISSAQUAH, WA,
WA
98027 -7018
|
|
Correspondent Contact |
AL VAN HOUDT |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/10/2005 |
Decision Date | 05/03/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|