510(k) K895881
K895881 is an FDA 510(k) premarket notification submitted by Baltimore Therapeutic Equipment Co. for the device "MOTIONSPECT". The FDA issued a decision of Substantially Equivalent on April 10, 1990. The device falls under product code LXW (Column, Adsorption, Low Density, Lipoprotein), a Class III device. Baltimore Therapeutic Equipment Co. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1990
- Date Received
- October 5, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Column, Adsorption, Low Density, Lipoprotein
- Device Class
- Class III
- Regulation Number
- Review Panel
- GU
- Submission Type