Device Classification Name |
oximeter
|
510(k) Number |
K863784 |
Device Name |
NELLCOR N-200 (PULSE OXIMETER) |
Applicant |
NELLCOR, INC. |
25495 WHITESELL ST. |
HAYWARD,
CA
94545
|
|
Applicant Contact |
BARBARA J BLACK |
Correspondent |
NELLCOR, INC. |
25495 WHITESELL ST. |
HAYWARD,
CA
94545
|
|
Correspondent Contact |
BARBARA J BLACK |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/26/1986 |
Decision Date | 11/21/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|