Clearance Summary
TYPE INTERFACE 9271/1 INCUBATOR/WARMER received FDA 510(k) clearance under submission number K912000, sponsored by S & W Medico Teknik. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1992-09-21.
- Submission: K912000
- Applicant / Sponsor: S & W Medico Teknik
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5400
- Decision date: 1992-09-21
Classification & Regulation
This clearance is catalogued under FDA product code FMZ and 21 CFR 880.5400, within the General Hospital review panel as a Class II device.