Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K081738 |
Device Name |
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 |
Applicant |
HEALTH & LIFE CO., LTD. |
PO BOX 993 A807 EL CAMINO |
SUIT C CARMICHAEL,
CA
95609
|
|
Applicant Contact |
SAMUEL PIPER |
Correspondent |
HEALTH & LIFE CO., LTD. |
PO BOX 993 A807 EL CAMINO |
SUIT C CARMICHAEL,
CA
95609
|
|
Correspondent Contact |
SAMUEL PIPER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 06/19/2008 |
Decision Date | 09/17/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|