Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K885314 |
Device Name |
HPD STERILE HUMIDIFYING CHAMBER |
Applicant |
HPD MEDICAL, INC. |
1000 CALLE NEGOCIO |
SAN CLEMENTE,
CA
92672 -6205
|
|
Applicant Contact |
DUNLAP |
Correspondent |
HPD MEDICAL, INC. |
1000 CALLE NEGOCIO |
SAN CLEMENTE,
CA
92672 -6205
|
|
Correspondent Contact |
DUNLAP |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 12/29/1988 |
Decision Date | 01/17/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|