Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K983996 |
Device Name |
SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM |
Applicant |
SPACELABS MEDICAL, INC. |
15220 N.E. 40TH ST. |
REDMOND,
WA
98073 -9713
|
|
Applicant Contact |
NANCY J GERTLAR |
Correspondent |
SPACELABS MEDICAL, INC. |
15220 N.E. 40TH ST. |
REDMOND,
WA
98073 -9713
|
|
Correspondent Contact |
NANCY J GERTLAR |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 11/10/1998 |
Decision Date | 06/03/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|