Device Classification Name |
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
|
510(k) Number |
K122281 |
Device Name |
PADNET 2.0 |
Applicant |
BIOMEDIX, INC. |
178 East 9th Street |
ST. PAUL,
MN
55101
|
|
Applicant Contact |
GREG HOCKING |
Correspondent |
BIOMEDIX, INC. |
178 East 9th Street |
ST. PAUL,
MN
55101
|
|
Correspondent Contact |
GREG HOCKING |
Regulation Number | 870.2780
|
Classification Product Code |
|
Date Received | 07/30/2012 |
Decision Date | 08/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|