TON-95LH, PAX-I3D ORTHO— 510(k) K132983
Substantially EquivalentVATECH Co., Ltd.
FDA 510(k) clearance K132983 for TON-95LH, PAX-I3D ORTHO, Substantially Equivalent on 2014-08-07. Applicant: VATECH Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- VATECH Co., Ltd.
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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