Device Classification Name |
circuit, breathing (w connector, adaptor, y piece)
|
510(k) Number |
K933641 |
Device Name |
BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE |
Applicant |
BIRD LIFE DESIGN |
4450 ALPHA RD. |
DALLAS,
TX
75244 -4505
|
|
Applicant Contact |
REBECCA D FULLER |
Correspondent |
BIRD LIFE DESIGN |
4450 ALPHA RD. |
DALLAS,
TX
75244 -4505
|
|
Correspondent Contact |
REBECCA D FULLER |
Regulation Number | 868.5240
|
Classification Product Code |
|
Date Received | 07/27/1993 |
Decision Date | 10/15/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|