Device Classification Name |
Condenser, Heat And Moisture (Artificial Nose)
|
510(k) Number |
K874597 |
Device Name |
THERMOVENT 600, 1200, T, 02 |
Applicant |
PORTEX, INC. |
42 INDUSTRIAL WAY |
WILMINGTON,
MA
01887
|
|
Applicant Contact |
EDWIN G GROVE |
Correspondent |
PORTEX, INC. |
42 INDUSTRIAL WAY |
WILMINGTON,
MA
01887
|
|
Correspondent Contact |
EDWIN G GROVE |
Regulation Number | 868.5375
|
Classification Product Code |
|
Date Received | 11/09/1987 |
Decision Date | 01/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|