Clearance Summary
MONITORS, REMOTE, RMS III received FDA 510(k) clearance under submission number K770721, sponsored by The Perkin-Elmer Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1977-04-28.
- Submission: K770721
- Applicant / Sponsor: The Perkin-Elmer Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1977-04-28
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.