Device Classification Name |
arterial blood sampling kit
|
510(k) Number |
K844615 |
Device Name |
BIOSAMPLER |
Applicant |
BIOTEK-CARIBBEAN |
APARADO POSTAL 2548 |
SANTO DOMINGO, DOM. REP.,
DO
|
|
Applicant Contact |
FEDERICO GARCIA-GODO |
Correspondent |
BIOTEK-CARIBBEAN |
APARADO POSTAL 2548 |
SANTO DOMINGO, DOM. REP.,
DO
|
|
Correspondent Contact |
FEDERICO GARCIA-GODO |
Regulation Number | 868.1100
|
Classification Product Code |
|
Date Received | 11/27/1984 |
Decision Date | 03/21/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|