Device Classification Name |
Oximeter
|
510(k) Number |
K020479 |
Device Name |
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES |
Applicant |
DATEX-OHMEDA |
86 PILGRIM RD. |
NEEDHAM,
MA
02492
|
|
Applicant Contact |
JOEL C KENT |
Correspondent |
DATEX-OHMEDA |
86 PILGRIM RD. |
NEEDHAM,
MA
02492
|
|
Correspondent Contact |
JOEL C KENT |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 02/13/2002 |
Decision Date | 03/26/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|