Device Classification Name |
monitor, airway pressure (includes gauge and/or alarm)
|
510(k) Number |
K000959 |
Device Name |
CRITERION 60 OR PM 60 |
Applicant |
CARADYNE, LTD. |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
CARADYNE, LTD. |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.2600
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/24/2000 |
Decision Date | 06/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|