Clearance Summary
JP-2 RESPIRATORY MONITORING SYSTEM received FDA 510(k) clearance under submission number K832005, sponsored by Morgan Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1983-12-29.
- Submission: K832005
- Applicant / Sponsor: Morgan Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1983-12-29
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.