Device Classification Name |
Accessory To Continuous Ventilator (Respirator)
|
510(k) Number |
K040712 |
Device Name |
AIR SAFETY HEPA, MODEL 3500 |
Applicant |
AIR SAFETY LTD |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
AIR SAFETY LTD |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/18/2004 |
Decision Date | 06/03/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|