510(k) K030869
K030869 is an FDA 510(k) premarket notification submitted by S.L.P. , Ltd. for the device "BITESTRIP". The FDA issued a decision of Substantially Equivalent on May 14, 2004. The device falls under product code KZM (Device, Muscle Monitoring), a Class II device regulated under 21 CFR 890.1375. S.L.P. , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2004
- Date Received
- March 19, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Muscle Monitoring
- Device Class
- Class II
- Regulation Number
- 890.1375
- Review Panel
- DE
- Submission Type