Device Classification Name |
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
|
510(k) Number |
K951485 |
Device Name |
AVOXIMETER 4000 |
Applicant |
A-VOX SYSTEMS, INC. |
15315 GREY FOX TERRACE |
SAN ANTONIO,
TX
78255
|
|
Applicant Contact |
A. P SHEPHERD |
Correspondent |
A-VOX SYSTEMS, INC. |
15315 GREY FOX TERRACE |
SAN ANTONIO,
TX
78255
|
|
Correspondent Contact |
A. P SHEPHERD |
Regulation Number | 862.3220
|
Classification Product Code |
|
Date Received | 03/30/1995 |
Decision Date | 11/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|