ID-Cap System— 510(k) K183052
Substantially EquivalentEtectrx, Inc.
FDA 510(k) clearance K183052 for ID-Cap System, Substantially Equivalent on 2019-12-06. Applicant: Etectrx, Inc.. Device class: 2.
Clearance details
- Applicant
- Etectrx, Inc.
- Product code
- Code OZW
- Device class
- Class 2
- Regulation
- 21 CFR 880.6305
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainesville, FL, US
Recent devices under product code OZW
view allData sourced from openFDA. This site is unofficial and independent of the FDA.