Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K924081 |
Device Name |
LUMISONIC |
Applicant |
LUMISCOPE CO., INC. |
400 RARITAN CENTER PKWY. |
EDISON,
NJ
08837
|
|
Applicant Contact |
STEPHEN WHITTENBURG |
Correspondent |
LUMISCOPE CO., INC. |
400 RARITAN CENTER PKWY. |
EDISON,
NJ
08837
|
|
Correspondent Contact |
STEPHEN WHITTENBURG |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 08/13/1992 |
Decision Date | 11/09/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|