Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K962872 |
Device Name |
RESPIFLO |
Applicant |
TYCO HEALTHCARE DEUTSCHALAND GMBH |
RAFFINERIESTR. 18 |
NEUSTADT A D DONAU,
DE
D-93333
|
|
Applicant Contact |
WILLIAM D CURTIN |
Correspondent |
TYCO HEALTHCARE DEUTSCHALAND GMBH |
RAFFINERIESTR. 18 |
NEUSTADT A D DONAU,
DE
D-93333
|
|
Correspondent Contact |
WILLIAM D CURTIN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/23/1996 |
Decision Date | 02/25/1997 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|