Clearance Summary
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 received FDA 510(k) clearance under submission number K852455, sponsored by Gambro, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-09-16.
- Submission: K852455
- Applicant / Sponsor: Gambro, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4200
- Decision date: 1985-09-16
Classification & Regulation
This clearance is catalogued under FDA product code KRI and 21 CFR 870.4200, within the Cardiovascular review panel as a Class I device.