Clearance Summary
MONITORING SYSTEM AS100-AS115 RECORD received FDA 510(k) clearance under submission number K832754, sponsored by Air-Shields, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1983-12-22.
- Submission: K832754
- Applicant / Sponsor: Air-Shields, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1983-12-22
Classification & Regulation
This clearance is catalogued under FDA product code DSF and 21 CFR 870.2810, within the Cardiovascular review panel as a Class I device.