Clearance Summary
CD-102 CARBON DIOXIDE ANALYZER/RECOR received FDA 510(k) clearance under submission number K833739, sponsored by Instrumentarium 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 1983-12-16.
- Submission: K833739
- Applicant / Sponsor: Instrumentarium Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1430
- Decision date: 1983-12-16
Classification & Regulation
This clearance is catalogued under FDA product code CCJ and 21 CFR 868.1430, within the Anesthesiology review panel as a Class II device.