SURETONE— 510(k) K011588
Substantially EquivalentSuretone International
FDA 510(k) clearance K011588 for SURETONE, Substantially Equivalent on 2002-03-28. Applicant: Suretone International. Device class: 2.
Clearance details
- Applicant
- Suretone International
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cape Town, Cape, ZA
Recent devices under product code IPF
view allData sourced from openFDA. This site is unofficial and independent of the FDA.