Device Classification Name |
Oximeter
|
510(k) Number |
K031465 |
Device Name |
MODEL 2100 PULSE OXIMETER |
Applicant |
DOLPHIN MEDICAL INC. |
13801 MCCORMICK DR. |
TAMPA,
FL
33626
|
|
Applicant Contact |
JON WERNER |
Correspondent |
DOLPHIN MEDICAL INC. |
13801 MCCORMICK DR. |
TAMPA,
FL
33626
|
|
Correspondent Contact |
JON WERNER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/08/2003 |
Decision Date | 10/10/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|