Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K992643 |
Device Name |
MODEL IRC 1001 AEROSOL COMPRESSOR |
Applicant |
INVACARE CORP. |
ONE INVACARE WAY |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Applicant Contact |
EDWARD A KROLL |
Correspondent |
INVACARE CORP. |
ONE INVACARE WAY |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Correspondent Contact |
EDWARD A KROLL |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 08/06/1999 |
Decision Date | 10/27/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|