The following data is part of a premarket notification filed by S.l.p. Ltd. with the FDA for Bitestrip.
| Device ID | K030869 |
| 510k Number | K030869 |
| Device Name: | BITESTRIP |
| Classification | Device, Muscle Monitoring |
| Applicant | S.L.P. LTD. 18 HAZFIRA ST. Tel-aviv, IL 67779 |
| Contact | Tamar Shochat |
| Correspondent | Tamar Shochat S.L.P. LTD. 18 HAZFIRA ST. Tel-aviv, IL 67779 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-19 |
| Decision Date | 2004-05-14 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BITESTRIP 78454714 3011062 Dead/Cancelled |
S.L.P. Ltd. 2004-07-22 |