Clearance Summary
DISPOSABLE TEMPERATURE PROBE received FDA 510(k) clearance under submission number K770353, sponsored by Inhal-O-Tech Medical Plastic. 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 1977-03-16.
- Submission: K770353
- Applicant / Sponsor: Inhal-O-Tech Medical Plastic
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2200
- Decision date: 1977-03-16
Classification & Regulation
This clearance is catalogued under FDA product code KPD and 21 CFR 880.2200, within the General Hospital review panel as a Class II device.