Clearance Summary
TA620 TREADMILL CONTROLLER received FDA 510(k) clearance under submission number K913518, sponsored by Siemens Burdick, 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 1991-10-24.
- Submission: K913518
- Applicant / Sponsor: Siemens Burdick, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1991-10-24
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.