Device Classification Name |
Humidifier, Non-Direct Patient Interface (Home-Use)
|
510(k) Number |
K894734 |
Device Name |
RHINOTHERM ULTRA 2 |
Applicant |
TWINMED PRODUCTS, INC. |
2601 OCEAN PARK BLVD. |
SANTA MONICA,
CA
90405
|
|
Applicant Contact |
EDWARD J FRANK |
Correspondent |
TWINMED PRODUCTS, INC. |
2601 OCEAN PARK BLVD. |
SANTA MONICA,
CA
90405
|
|
Correspondent Contact |
EDWARD J FRANK |
Regulation Number | 868.5460
|
Classification Product Code |
|
Date Received | 07/24/1989 |
Decision Date | 02/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|