Device Classification Name |
monitor, cardiac (incl. cardiotachometer & rate alarm)
|
510(k) Number |
K760120 |
Device Name |
PULSE CARDULE (MODEL 1859/1860 ECG) |
Applicant |
SPACELABS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SPACELABS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 06/28/1976 |
Decision Date | 07/20/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|