Device Classification Name |
device, muscle monitoring
|
510(k) Number |
K030869 |
Device Name |
BITESTRIP |
Applicant |
S.L.P. LTD. |
18 HAZFIRA ST. |
TEL-AVIV,
IL
67779
|
|
Applicant Contact |
TAMAR SHOCHAT |
Correspondent |
S.L.P. LTD. |
18 HAZFIRA ST. |
TEL-AVIV,
IL
67779
|
|
Correspondent Contact |
TAMAR SHOCHAT |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 03/19/2003 |
Decision Date | 05/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|