CYCLETRAC CT-5000— 510(k) K073542
Substantially EquivalentPt Products, LLC
FDA 510(k) clearance K073542 for CYCLETRAC CT-5000, Substantially Equivalent on 2008-02-14. Applicant: Pt Products, LLC. Device class: 2.
Clearance details
- Applicant
- Pt Products, LLC
- 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
- Farmington Hills, MI, US
Recent devices under product code ITH
view allData sourced from openFDA. This site is unofficial and independent of the FDA.