Clearance Summary
INTRA-ALERT received FDA 510(k) clearance under submission number K781297, sponsored by Pan-Tech Research, 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 1978-10-25.
- Submission: K781297
- Applicant / Sponsor: Pan-Tech Research, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2420
- Decision date: 1978-10-25
Classification & Regulation
This clearance is catalogued under FDA product code FLN and 21 CFR 880.2420, within the General Hospital review panel as a Class II device.