Device Classification Name |
calculator, pulmonary function interpretor (diagnostic)
|
510(k) Number |
K974200 |
Device Name |
ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM |
Applicant |
ORCA DIAGNOSTICS CORP. |
P.O. BOX 1951 |
LOS ALTOS,
CA
94019
|
|
Applicant Contact |
SHEILA W PICKERING |
Correspondent |
ORCA DIAGNOSTICS CORP. |
P.O. BOX 1951 |
LOS ALTOS,
CA
94019
|
|
Correspondent Contact |
SHEILA W PICKERING |
Regulation Number | 868.1900
|
Classification Product Code |
|
Date Received | 11/10/1997 |
Decision Date | 07/21/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|