ITRAC CERVICAL TRACTION SYSTEM— 510(k) K131983
Substantially EquivalentPivotal Health Solutions
FDA 510(k) clearance K131983 for ITRAC CERVICAL TRACTION SYSTEM, Substantially Equivalent on 2014-09-10. Applicant: Pivotal Health Solutions. Device class: 2.
Clearance details
- Applicant
- Pivotal Health Solutions
- Product code
- Code ITH
- Device class
- Class 2
- Regulation
- 21 CFR 890.5900
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Watertown, SD, US
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