Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K003368 |
Device Name |
ACROTHERM |
Applicant |
AQUARIUS MEDICAL CORP. |
16047 NORTH 82ND ST. |
SUITE B-1 |
SCOTTSDALE,
AZ
85260
|
|
Applicant Contact |
CHRISTINA M FLEMING |
Correspondent |
AQUARIUS MEDICAL CORP. |
16047 NORTH 82ND ST. |
SUITE B-1 |
SCOTTSDALE,
AZ
85260
|
|
Correspondent Contact |
CHRISTINA M FLEMING |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 10/30/2000 |
Decision Date | 01/19/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|