Clearance Summary
VITALOGRAPH-EC60 HYDROGEN MONITOR received FDA 510(k) clearance under submission number K874892, sponsored by Vitalograph , Ltd.. 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 1988-06-02.
- Submission: K874892
- Applicant / Sponsor: Vitalograph , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1820
- Decision date: 1988-06-02
Classification & Regulation
This clearance is catalogued under FDA product code NRH and 21 CFR 862.1820, within the Clinical Chemistry review panel as a Class I device.