Clearance Summary
LIFE WATCH RESPIRATORY MONITOR received FDA 510(k) clearance under submission number K853840, sponsored by The Perkin-Elmer Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1985-12-09.
- Submission: K853840
- Applicant / Sponsor: The Perkin-Elmer Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1120
- Decision date: 1985-12-09
Classification & Regulation
This clearance is catalogued under FDA product code CHL and 21 CFR 862.1120, within the Clinical Chemistry review panel as a Class II device.