Device Classification Name |
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
|
510(k) Number |
K832793 |
Device Name |
NEOCATH 1000 W/HEPCOTE |
Applicant |
ORANGE MEDICAL INSTRUMENTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ORANGE MEDICAL INSTRUMENTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.1200
|
Classification Product Code |
|
Date Received | 08/19/1983 |
Decision Date | 09/26/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|