Device Classification Name |
exerciser, measuring
|
510(k) Number |
K143512 |
Device Name |
ActiSpec Activity Monitor |
Applicant |
SLEEP MODUS, INC. |
1201 RICHARDSON DRIVE, SUITE 280-B |
RICHARDSON,
TX
75080
|
|
Applicant Contact |
STANFORD P HUDSON |
Correspondent |
KEN BLOCK CONSULTING |
1201 RICHARDSON DRIVE |
SUITE 280 |
RICHARDSON,
TX
75080 -4403
|
|
Correspondent Contact |
DIANE RUTHERFORD |
Regulation Number | 890.5360
|
Classification Product Code |
|
Date Received | 12/11/2014 |
Decision Date | 08/26/2015 |
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
|
|
|