Device Classification Name |
Condenser, Heat And Moisture (Artificial Nose)
|
510(k) Number |
K934190 |
Device Name |
HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION |
Applicant |
BIRD LIFE DESIGN |
4450 ALPHA RD. |
DALLAS,
TX
75244 -4505
|
|
Applicant Contact |
EBECCA D FULLER |
Correspondent |
BIRD LIFE DESIGN |
4450 ALPHA RD. |
DALLAS,
TX
75244 -4505
|
|
Correspondent Contact |
EBECCA D FULLER |
Regulation Number | 868.5375
|
Classification Product Code |
|
Date Received | 08/26/1993 |
Decision Date | 11/24/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|