Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K032922 |
Device Name |
CLARISSA INFANT NCPAP CANNULA |
Applicant |
AIRWAYS LTD., INC. |
P.O.BOX 558 |
CEDAR KNOLLS,
NJ
07927
|
|
Applicant Contact |
RICHARD J LARKIN |
Correspondent |
AIRWAYS LTD., INC. |
P.O.BOX 558 |
CEDAR KNOLLS,
NJ
07927
|
|
Correspondent Contact |
RICHARD J LARKIN |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/22/2003 |
Decision Date | 09/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|