Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K983783 |
Device Name |
HEATED HUMIDIFIER |
Applicant |
PEGASUS RESEARCH CORP. |
1714 SOUTH LYON ST. |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
E J SMITH |
Correspondent |
PEGASUS RESEARCH CORP. |
1714 SOUTH LYON ST. |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
E J SMITH |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 10/27/1998 |
Decision Date | 10/24/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|