Clearance Summary
VIEWSEND MEDICAL MODEL 1200 received FDA 510(k) clearance under submission number K962225, sponsored by Klt Telecom, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-10-25.
- Submission: K962225
- Applicant / Sponsor: Klt Telecom, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1996-10-25
Classification & Regulation
This clearance is catalogued under FDA product code LMD and 21 CFR 892.2020, within the Radiology review panel as a Class I device.