Clearance Summary
WARM WEIGH MODEL N-10 INFANT SCALE received FDA 510(k) clearance under submission number K870888, sponsored by Air-Shields, 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 1987-03-17.
- Submission: K870888
- Applicant / Sponsor: Air-Shields, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2720
- Decision date: 1987-03-17
Classification & Regulation
This clearance is catalogued under FDA product code FRW and 21 CFR 880.2720, within the General Hospital review panel as a Class I device.