Clearance Summary
THE SAFETY 1ST DIGITAL PACIFIER received FDA 510(k) clearance under submission number K963276, sponsored by Safety 1st, 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 1996-12-06.
- Submission: K963276
- Applicant / Sponsor: Safety 1st, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1996-12-06
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.