AXXENT CERVICAL APPLICATOR— 510(k) K141343
Substantially EquivalentIcad, Inc.
FDA 510(k) clearance K141343 for AXXENT CERVICAL APPLICATOR, Substantially Equivalent on 2014-09-05. Applicant: Icad, Inc.. Device class: 2.
Clearance details
- Applicant
- Icad, Inc.
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nashua, NH, US
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