Cleared Traditional

K030869 - BITESTRIP
(FDA 510(k) Clearance)

K030869 · S.L.P. , Ltd. · Dental
May 2004
Decision
422d
Days
Class 2
Risk

K030869 is an FDA 510(k) clearance for the BITESTRIP, a Device, Muscle Monitoring (Class II — Special Controls, product code KZM), submitted by S.L.P. , Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on May 14, 2004, 422 days after receiving the submission on March 19, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K030869 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2003
Decision Date May 14, 2004
Days to Decision 422 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KZM — Device, Muscle Monitoring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1375