510(k) K873774
K873774 is an FDA 510(k) premarket notification submitted by Burdick Corp. for the device "M300 MONITOR/CONTROLLER T500 TREADMILL". The FDA issued a decision of Substantially Equivalent on November 6, 1987. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Burdick Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1987
- Date Received
- September 16, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Cathode-Ray Tube, Medical
- Device Class
- Class II
- Regulation Number
- 870.2450
- Review Panel
- CV
- Submission Type