Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K915890 |
Device Name |
AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED |
Applicant |
PEGASUS RESEARCH CORP. |
3001 REDHILL AVE., SUITE 4- |
119 |
COSTA MESA,
CA
92626
|
|
Applicant Contact |
WILLIAM BURKE |
Correspondent |
PEGASUS RESEARCH CORP. |
3001 REDHILL AVE., SUITE 4- |
119 |
COSTA MESA,
CA
92626
|
|
Correspondent Contact |
WILLIAM BURKE |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 12/24/1991 |
Decision Date | 06/24/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|