Clearance Summary
SKYNDEX ELECTRONIC BODY FAT CALCULA received FDA 510(k) clearance under submission number K841687, sponsored by Caldwell, Justiss & Co., 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 1984-06-28.
- Submission: K841687
- Applicant / Sponsor: Caldwell, Justiss & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4150
- Decision date: 1984-06-28
Classification & Regulation
This clearance is catalogued under FDA product code KTZ and 21 CFR 888.4150, within the Orthopedic review panel as a Class I device.