Clearance Summary
Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement received FDA 510(k) clearance under submission number K153026, sponsored by Medtec, Inc. D/B/A Civco Medical Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-05-25.
- Submission: K153026
- Applicant / Sponsor: Medtec, Inc. D/B/A Civco Medical Solutions
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2016-05-25
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.