Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K042655 |
Device Name |
INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 |
Applicant |
RESPIRONICS NEW JERSEY, INC. |
41 CANFIELD RD. |
CEDAR GROVE,
NJ
07009
|
|
Applicant Contact |
Lauren Ziegler |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 868.5630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/28/2004 |
Decision Date | 10/13/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|