Device Classification Name |
Oximeter
|
510(k) Number |
K102442 |
Device Name |
E.S.O. (ELECTRO SENSOR OXI) |
Applicant |
L.D. TECHNOLOGY, LLC |
100 N. BISCAYNE BLVD |
SUITE 500 |
MIAMI,
FL
33132
|
|
Applicant Contact |
ALBERT MAAREK |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/26/2010 |
Decision Date | 09/10/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|