Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K113231 |
Device Name |
WARP10,WARP75 |
Applicant |
QUANTUM DEVICES, INC. |
1920 ARLINGTON PL. |
MEDISON,
WI
53726
|
|
Applicant Contact |
MORRIS WAXLER |
Correspondent |
QUANTUM DEVICES, INC. |
1920 ARLINGTON PL. |
MEDISON,
WI
53726
|
|
Correspondent Contact |
MORRIS WAXLER |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 11/02/2011 |
Decision Date | 02/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|