Device Classification Name |
Oximeter
|
510(k) Number |
K062724 |
Device Name |
ACCUPULSE PULSE OXIMETER |
Applicant |
EAGLE MEDICAL EQUIPMENT CO. |
537 N SPENCER |
MESA,
AZ
85203
|
|
Applicant Contact |
JAMES A DUNNING |
Correspondent |
EAGLE MEDICAL EQUIPMENT CO. |
537 N SPENCER |
MESA,
AZ
85203
|
|
Correspondent Contact |
JAMES A DUNNING |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/12/2006 |
Decision Date | 05/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|