Clearance Summary
RECORDER, STRIP CHART WITH PRINTER received FDA 510(k) clearance under submission number K781873, sponsored by Midwest Analog & Digital, 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 1979-01-05.
- Submission: K781873
- Applicant / Sponsor: Midwest Analog & Digital, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1979-01-05
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.