Clearance Summary
BABYTHERM 8004 BABYTHERM 8010 received FDA 510(k) clearance under submission number K971198, sponsored by Drager, 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 1997-10-03.
- Submission: K971198
- Applicant / Sponsor: Drager, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 1997-10-03
Classification & Regulation
This clearance is catalogued under FDA product code FMT and 21 CFR 880.5130, within the General Hospital review panel as a Class II device.