Clearance Summary
H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP received FDA 510(k) clearance under submission number K871351, sponsored by Holter-Hausner Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1987-05-14.
- Submission: K871351
- Applicant / Sponsor: Holter-Hausner Intl.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 1987-05-14
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.