Clearance Summary
PEE WEE THERMOMETERS received FDA 510(k) clearance under submission number K853515, sponsored by Joel R.L. Ehren Kranz. 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 1985-10-16.
- Submission: K853515
- Applicant / Sponsor: Joel R.L. Ehren Kranz
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2900
- Decision date: 1985-10-16
Classification & Regulation
This clearance is catalogued under FDA product code FQZ and 21 CFR 880.2900, within the General Hospital review panel as a Class I device.