Device Classification Name |
oximeter, ear
|
510(k) Number |
K944760 |
Device Name |
DURA-Y OXYGEN TRANSDUCER, EAR CLIP |
Applicant |
NELLCOR, INC. |
2391 FENTON ST. |
CHULA VISTA,
CA
91914 -3511
|
|
Applicant Contact |
GERALD PALECKI |
Correspondent |
NELLCOR, INC. |
2391 FENTON ST. |
CHULA VISTA,
CA
91914 -3511
|
|
Correspondent Contact |
GERALD PALECKI |
Regulation Number | 870.2710
|
Classification Product Code |
|
Date Received | 09/27/1994 |
Decision Date | 10/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|