Clearance Summary
ID BRACLETS, ADULT & INFANT received FDA 510(k) clearance under submission number K771158, sponsored by Divers-A-Med. 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 1977-10-13.
- Submission: K771158
- Applicant / Sponsor: Divers-A-Med
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1977-10-13
Classification & Regulation
This clearance is catalogued under FDA product code LDR and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.