Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K043276 |
Device Name |
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE |
Applicant |
DATEX-OHMEDA |
86 PILGRIM RD. |
NEEDHAM,
MA
02492
|
|
Applicant Contact |
JOEL KENT |
Correspondent |
DATEX-OHMEDA |
86 PILGRIM RD. |
NEEDHAM,
MA
02492
|
|
Correspondent Contact |
JOEL KENT |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 11/26/2004 |
Decision Date | 12/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|