Device Classification Name |
set, tubing and support, ventilator (w harness)
|
510(k) Number |
K863033 |
Device Name |
PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS |
Applicant |
INTERTECH/OHIO |
5030 TICE ST. |
FORT MYERS,
FL
33905
|
|
Applicant Contact |
J. E BLAKE |
Correspondent |
INTERTECH/OHIO |
5030 TICE ST. |
FORT MYERS,
FL
33905
|
|
Correspondent Contact |
J. E BLAKE |
Regulation Number | 868.5975
|
Classification Product Code |
|
Date Received | 08/11/1986 |
Decision Date | 08/20/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|