Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K993608 |
Device Name |
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) |
Applicant |
DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Applicant Contact |
JOEL C KENT |
Correspondent |
DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Correspondent Contact |
JOEL C KENT |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 10/25/1999 |
Decision Date | 04/13/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|