Clearance Summary
DATALOGGER CHART RECORDER received FDA 510(k) clearance under submission number K880781, 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 1988-05-11.
- Submission: K880781
- Applicant / Sponsor: Air-Shields, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1988-05-11
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.