Clearance Summary
SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 received FDA 510(k) clearance under submission number K924433, sponsored by Senior Technologies, Inc.. 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 1993-06-24.
- Submission: K924433
- Applicant / Sponsor: Senior Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2400
- Decision date: 1993-06-24
Classification & Regulation
This clearance is catalogued under FDA product code KMI and 21 CFR 880.2400, within the General Hospital review panel as a Class I device.