EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING

Clearance Summary

EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING received FDA 510(k) clearance under submission number K002598, sponsored by J. H. Emerson Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2000-11-22.

• Submission: K002598
• Applicant / Sponsor: J. H. Emerson Co.
• Clearance pathway: Special
• Review panel: Anesthesiology
• Device class: Class II
• Regulation citation: 21 CFR 868.5905
• Decision date: 2000-11-22

Classification & Regulation

This clearance is catalogued under FDA product code NHJ and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.