Clearance Summary
TEXAS INTERFACE PRESSURE EVALUATOR-TIPE received FDA 510(k) clearance under submission number K831800, sponsored by Tee-Kay Applied Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1983-08-16.
- Submission: K831800
- Applicant / Sponsor: Tee-Kay Applied Technology
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.1600
- Decision date: 1983-08-16
Classification & Regulation
This clearance is catalogued under FDA product code JFC and 21 CFR 890.1600, within the Physical Medicine review panel as a Class I device.