Clearance Summary
FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT received FDA 510(k) clearance under submission number K932417, sponsored by Ferno-Washington, Inc.. 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 1993-09-09.
- Submission: K932417
- Applicant / Sponsor: Ferno-Washington, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5410
- Decision date: 1993-09-09
Classification & Regulation
This clearance is catalogued under FDA product code FPL and 21 CFR 880.5410, within the General Hospital review panel as a Class II device.