Device Classification Name |
insufflator, automatic carbon-dioxide for endoscope
|
510(k) Number |
K935059 |
Device Name |
INSUFFLATION TUBING SET, PHX500-082 |
Applicant |
PHX TECHNOLOGIES CORP. |
POST OFFICE BOX 1059 |
LEWISVILLE,
TX
75067
|
|
Applicant Contact |
JAMES F CHAPEL |
Correspondent |
PHX TECHNOLOGIES CORP. |
POST OFFICE BOX 1059 |
LEWISVILLE,
TX
75067
|
|
Correspondent Contact |
JAMES F CHAPEL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/21/1993 |
Decision Date | 12/22/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|