The following data is part of a premarket notification filed by Baltimore Therapeutic Equipment Co. with the FDA for Motionspect.
| Device ID | K895881 |
| 510k Number | K895881 |
| Device Name: | MOTIONSPECT |
| Classification | Column, Adsorption, Low Density, Lipoprotein |
| Applicant | BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455-L NEW RIDGE RD. Hanover, MD 21076 |
| Contact | Day Iii |
| Correspondent | Day Iii BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455-L NEW RIDGE RD. Hanover, MD 21076 |
| Product Code | LXW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-05 |
| Decision Date | 1990-04-10 |