Clearance Summary
MASS SPECTROMETRY MONITORING LINES AND CONNECTORS received FDA 510(k) clearance under submission number K942567, sponsored by Med-Plastics Intl., 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 1994-06-10.
- Submission: K942567
- Applicant / Sponsor: Med-Plastics Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1994-06-10
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.