Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K930524 |
Device Name |
END TIDAL CO2 OPTION B |
Applicant |
MEDICAL DATA ELECTRONICS |
12720 WENTWORTH ST. |
ARLETA,
CA
91331
|
|
Applicant Contact |
JIM ROOKS |
Correspondent |
MEDICAL DATA ELECTRONICS |
12720 WENTWORTH ST. |
ARLETA,
CA
91331
|
|
Correspondent Contact |
JIM ROOKS |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 02/02/1993 |
Decision Date | 02/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|