Clearance Summary
RELIANCE TEMPO OPHTH. INSTR STAND received FDA 510(k) clearance under submission number K831568, sponsored by F. & F. Koenigkramer. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1983-06-30.
- Submission: K831568
- Applicant / Sponsor: F. & F. Koenigkramer
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1983-06-30
Classification & Regulation
This clearance is catalogued under FDA product code HHF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.