Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K843932 |
Device Name |
VAPOR-PHASE HUMIDIFIER SYS-ADVANCED |
Applicant |
INSPIRON CORP. |
8600 ARCHIBALD AVE. |
RANCHO CUCAMONGA,
CA
91730
|
|
Applicant Contact |
THOMAS C BREWSTER |
Correspondent |
INSPIRON CORP. |
8600 ARCHIBALD AVE. |
RANCHO CUCAMONGA,
CA
91730
|
|
Correspondent Contact |
THOMAS C BREWSTER |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 10/05/1984 |
Decision Date | 10/18/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|