Clearance Summary
AS/3 ESTPR MODULE received FDA 510(k) clearance under submission number K953175, sponsored by Datex Division Instrumentarium Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-02-06.
- Submission: K953175
- Applicant / Sponsor: Datex Division Instrumentarium Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1997-02-06
Classification & Regulation
This clearance is catalogued under FDA product code MLD and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.