Device Classification Name |
humidifier, non-direct patient interface (home-use)
|
510(k) Number |
K915603 |
Device Name |
VIROTHERM HUMIDIFIER |
Applicant |
VIROTHERM LABORATORY |
13485 OLD OAK WAY |
SARATOGA,
CA
95070 -4206
|
|
Applicant Contact |
WILLIAM PERETTI |
Correspondent |
VIROTHERM LABORATORY |
13485 OLD OAK WAY |
SARATOGA,
CA
95070 -4206
|
|
Correspondent Contact |
WILLIAM PERETTI |
Regulation Number | 868.5460
|
Classification Product Code |
|
Date Received | 12/16/1991 |
Decision Date | 10/22/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|