Clearance Summary
M-2 OXYGEN/TEMPERATURE MONITOR received FDA 510(k) clearance under submission number K871337, sponsored by Bio-Med Devices, 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 1987-06-05.
- Submission: K871337
- Applicant / Sponsor: Bio-Med Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 1987-06-05
Classification & Regulation
This clearance is catalogued under FDA product code CCL and 21 CFR 868.1720, within the Anesthesiology review panel as a Class II device.