CODA MPX30 MOTION ANALYSIS SYSTEM
FDA 510(k) clearance K982425 · decided 1998-10-07
Clearance details
- K-number
- K982425
- Device name
- CODA MPX30 MOTION ANALYSIS SYSTEM
- Applicant
- Pinsco Inc. Dba B & L Engineering
- Decision
- Substantially Equivalent
- Date received
- 1998-07-13
- Decision date
- 1998-10-07
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- LXJ
- Device class
- 2
- Regulation number
- 890.5360
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.