Clearance Summary
VASCULAR LABORATORY TREADMILL VT1 received FDA 510(k) clearance under submission number K833588, sponsored by Medasonics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1983-11-14.
- Submission: K833588
- Applicant / Sponsor: Medasonics, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1983-11-14
Classification & Regulation
This clearance is catalogued under FDA product code IOL and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.