Clearance Summary
MSI STANDARD BED MODELS: L1097-64 AND L1085-64 received FDA 510(k) clearance under submission number K881961, sponsored by Med Service, 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 1988-11-01.
- Submission: K881961
- Applicant / Sponsor: Med Service, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5120
- Decision date: 1988-11-01
Classification & Regulation
This clearance is catalogued under FDA product code FNJ and 21 CFR 880.5120, within the General Hospital review panel as a Class I device.