Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K925510 |
Device Name |
MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING |
Applicant |
SPACELABS MEDICAL, INC. |
925 SHERMAN AVE. |
HAMDEN,
CT
06514
|
|
Applicant Contact |
RAYMOND W GIFFORD |
Correspondent |
SPACELABS MEDICAL, INC. |
925 SHERMAN AVE. |
HAMDEN,
CT
06514
|
|
Correspondent Contact |
RAYMOND W GIFFORD |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 10/30/1992 |
Decision Date | 10/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|