Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K022465 |
Device Name |
MODIFICATION TO NASAL-AIRE |
Applicant |
INNOMED TECHNOLOGIES |
506 GARDEN STREET |
GREENSBURG,
PA
15601
|
|
Applicant Contact |
MARGE WALLS-WALKER |
Correspondent |
INNOMED TECHNOLOGIES |
506 GARDEN STREET |
GREENSBURG,
PA
15601
|
|
Correspondent Contact |
MARGE WALLS-WALKER |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/26/2002 |
Decision Date | 03/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|