Device Classification Name |
plethysmograph, impedance
|
510(k) Number |
K112830 |
Device Name |
ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) |
Applicant |
NONINVASIVE MEDICAL TECHNOLOGIES, INC. |
6412 S. ARVILLE STREET |
LAS VEGAS,
NV
89118
|
|
Applicant Contact |
MARC O'GRIOFA |
Correspondent |
NONINVASIVE MEDICAL TECHNOLOGIES, INC. |
6412 S. ARVILLE STREET |
LAS VEGAS,
NV
89118
|
|
Correspondent Contact |
MARC O'GRIOFA |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 09/28/2011 |
Decision Date | 11/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|