Device Classification Name |
oximeter
|
510(k) Number |
K162580 |
Device Name |
Guardian Angel GA1000 Digital Vital Sign Monitoring System |
Applicant |
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. |
RM. 1052, BLDG.H, 10F., NO.3-2, YUANQU ST., NANGANG DIST. |
TAIPEI CITY,
TW
115
|
|
Applicant Contact |
ALAN TANG |
Correspondent |
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. |
725 MORNINGHOME RD |
DANVILLE,
CA
94526
|
|
Correspondent Contact |
DON MIZOTA |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/15/2016 |
Decision Date | 03/03/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|