Clearance Summary
MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS received FDA 510(k) clearance under submission number K130097, sponsored by American Medical Manufacturing, Inc./ Advanced 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 2014-07-22.
- Submission: K130097
- Applicant / Sponsor: American Medical Manufacturing, Inc./ Advanced Med
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2014-07-22
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.