Device Classification Name |
ventilator, external body, negative pressure, adult (cuirass)
|
510(k) Number |
K893213 |
Device Name |
EASY BREATHER MODEL 100 |
Applicant |
PROGRESSIVE PRODUCTIONS LTD. |
70 ARCHWOOD DR. |
MOHRSVILLE,
PA
19541
|
|
Applicant Contact |
GENEVIEVE M BOGUSKY |
Correspondent |
PROGRESSIVE PRODUCTIONS LTD. |
70 ARCHWOOD DR. |
MOHRSVILLE,
PA
19541
|
|
Correspondent Contact |
GENEVIEVE M BOGUSKY |
Regulation Number | 868.5935
|
Classification Product Code |
|
Date Received | 04/27/1989 |
Decision Date | 08/04/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|