Clearance Summary
PLANER BT37 INCUBATOR received FDA 510(k) clearance under submission number K121566, sponsored by Planer Plc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2012-11-29.
- Submission: K121566
- Applicant / Sponsor: Planer Plc
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6120
- Decision date: 2012-11-29
Classification & Regulation
This clearance is catalogued under FDA product code MQG and 21 CFR 884.6120, within the Obstetrics/Gynecology review panel as a Class II device.