Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
510(k) Number |
K953055 |
Device Name |
MISTASSIST BREATHING EXERCISER |
Applicant |
THE MERLIN CORP. |
1127 GARRIDO DR. |
CAMARILLO,
CA
93010
|
|
Applicant Contact |
PAUL DWORK |
Correspondent |
THE MERLIN CORP. |
1127 GARRIDO DR. |
CAMARILLO,
CA
93010
|
|
Correspondent Contact |
PAUL DWORK |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 06/30/1995 |
Decision Date | 02/08/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|