Device Classification Name |
Oximeter
|
510(k) Number |
K014294 |
Device Name |
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 |
Applicant |
MEDICAL DATA ELECTRONICS |
12723 WENTWORTH ST. |
ARLETA,
CA
91331
|
|
Applicant Contact |
GREGORY ALKIRE |
Correspondent |
MEDICAL DATA ELECTRONICS |
12723 WENTWORTH ST. |
ARLETA,
CA
91331
|
|
Correspondent Contact |
GREGORY ALKIRE |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/28/2001 |
Decision Date | 01/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|