Device Classification Name |
Oximeter
|
510(k) Number |
K882273 |
Device Name |
HORIZON 2000 PULSE OXIMETRY AND MODULE |
Applicant |
MENNEN MEDICAL, INC. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Applicant Contact |
THOMAS W CONNELLY |
Correspondent |
MENNEN MEDICAL, INC. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Correspondent Contact |
THOMAS W CONNELLY |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/31/1988 |
Decision Date | 08/25/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|