Clearance Summary
PEDI-SPIDER STRAP received FDA 510(k) clearance under submission number K061721, sponsored by Emergency Products and Research. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2006-08-17.
- Submission: K061721
- Applicant / Sponsor: Emergency Products and Research
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6900
- Decision date: 2006-08-17
Classification & Regulation
This clearance is catalogued under FDA product code NZD and 21 CFR 880.6900, within the General Hospital review panel as a Class I device.