Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K013421 |
Device Name |
LIFEGUARD NASAL CPAP MASK AND ACCESSORIES |
Applicant |
LIFEGUARD MEDICAL PRODUCTS, INC. |
120 ELM DR. |
PLAINFIELD,
IN
46168
|
|
Applicant Contact |
CRAIG JOHNSON |
Correspondent |
LIFEGUARD MEDICAL PRODUCTS, INC. |
120 ELM DR. |
PLAINFIELD,
IN
46168
|
|
Correspondent Contact |
CRAIG JOHNSON |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 10/16/2001 |
Decision Date | 01/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|