Clearance Summary
PARATHERM received FDA 510(k) clearance under submission number K821049, sponsored by American Thermometer Company, Inc.. 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 1982-04-29.
- Submission: K821049
- Applicant / Sponsor: American Thermometer Company, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2982
- Decision date: 1982-04-29
Classification & Regulation
This clearance is catalogued under FDA product code KYA and 21 CFR 884.2982, within the Obstetrics/Gynecology review panel as a Class I device.