Clearance Summary
MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS received FDA 510(k) clearance under submission number K884165, sponsored by Spark Instruments & Academics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1988-10-26.
- Submission: K884165
- Applicant / Sponsor: Spark Instruments & Academics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1240
- Decision date: 1988-10-26
Classification & Regulation
This clearance is catalogued under FDA product code LBB and 21 CFR 888.1240, within the Orthopedic review panel as a Class II device.