FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CODA MPX30 MOTION ANALYSIS SYSTEM
K Number: K982425
·
Decision Oct 7, 1998
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
26
Applicant Total
2
Review Days
86
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Basic Information
- Device Name
- CODA MPX30 MOTION ANALYSIS SYSTEM
- K Number
- K982425
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pinsco Inc. Dba B & L Engineering
- Date Received
- July 13, 1998
- Decision Date
- October 7, 1998
- Product Code
- LXJ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| LXJ | Interactive Rehabilitation Exercise Devices | FDA class 2 | Physical Medicine |
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Other Clearances by Pinsco Inc. Dba B & L Engineering
| K Number | Device Name | ||
|---|---|---|---|
| K111443 | X12 STERILE REFLECTIVE MARKER SPHERE | Sep 29, 2011 | Substantially Equivalent |