Device Classification Name |
Calculator, Pulmonary Function Interpretor (Diagnostic)
|
510(k) Number |
K853190 |
Device Name |
SUPERSPIRO |
Applicant |
CDX CORP. |
10691 E. BETHANY DR. #900 |
AURORA,
CO
80014
|
|
Applicant Contact |
DAVID E LYNN |
Correspondent |
CDX CORP. |
10691 E. BETHANY DR. #900 |
AURORA,
CO
80014
|
|
Correspondent Contact |
DAVID E LYNN |
Regulation Number | 868.1900
|
Classification Product Code |
|
Date Received | 07/30/1985 |
Decision Date | 09/26/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|