Clearance Summary
INFORMED REMOTE FIELD UNIT MODEL IFM1000 received FDA 510(k) clearance under submission number K821712, sponsored by Burditt & Calkins-Siemens-Elema. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1982-07-26.
- Submission: K821712
- Applicant / Sponsor: Burditt & Calkins-Siemens-Elema
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 1982-07-26
Classification & Regulation
This clearance is catalogued under FDA product code BTY and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.