FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MOTIONSPECT
K Number: K895881
·
Decision Apr 10, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
187
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Basic Information
- Device Name
- MOTIONSPECT
- K Number
- K895881
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Baltimore Therapeutic Equipment Co.
- Date Received
- October 5, 1989
- Decision Date
- April 10, 1990
- Product Code
- LXW
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LXW | Column, Adsorption, Low Density, Lipoprotein | FDA class 3 | Unknown |
Other Clearances by Baltimore Therapeutic Equipment Co.
| K Number | Device Name | ||
|---|---|---|---|
| K955106 | BTE CPM-20 | Dec 29, 1995 | Substantially Equivalent |
| K955105 | BTE CPM-10 | Dec 29, 1995 | Substantially Equivalent |
| K925225 | THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK | Jun 27, 1994 | Substantially Equivalent |
| K933611 | THE BTE WS30 | Jun 20, 1994 | Substantially Equivalent |
| K924414 | THE BTE DYNAMIC LIFT | Feb 12, 1993 | Substantially Equivalent |
| K800007 | WORK SIMULATOR | Jan 21, 1980 | Substantially Equivalent |