Clearance Summary
EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER received FDA 510(k) clearance under submission number K902042, sponsored by Em-Scan, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-07-26.
- Submission: K902042
- Applicant / Sponsor: Em-Scan, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 1990-07-26
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.