Device Classification Name |
circuit, breathing (w connector, adaptor, y piece)
|
510(k) Number |
K881141 |
Device Name |
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT |
Applicant |
BAXTER HEALTHCARE CORP. |
27200 NORTH TOURNEY RD. |
P.O. BOX 5900 |
VALENCIA,
CA
91355 -8900
|
|
Applicant Contact |
LAWRENCE W GETLIN |
Correspondent |
BAXTER HEALTHCARE CORP. |
27200 NORTH TOURNEY RD. |
P.O. BOX 5900 |
VALENCIA,
CA
91355 -8900
|
|
Correspondent Contact |
LAWRENCE W GETLIN |
Regulation Number | 868.5240
|
Classification Product Code |
|
Date Received | 03/17/1988 |
Decision Date | 04/25/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|