Device Classification Name |
oximeter, reprocessed
|
510(k) Number |
K042316 |
Device Name |
VANGUARD REPROCESSED PULSE OXIMETER SENSORS |
Applicant |
VANGUARD MEDICAL CONCEPTS, INC. |
5307 GREAT OAK DR. |
LAKELAND,
FL
33815
|
|
Applicant Contact |
HEATHER CRAWFORD |
Correspondent |
VANGUARD MEDICAL CONCEPTS, INC. |
5307 GREAT OAK DR. |
LAKELAND,
FL
33815
|
|
Correspondent Contact |
HEATHER CRAWFORD |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/26/2004 |
Decision Date | 01/06/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|