QMASTER-H/REVO— 510(k) K133797
Substantially EquivalentTelesystems Co., Ltd.
FDA 510(k) clearance K133797 for QMASTER-H/REVO, Substantially Equivalent on 2014-09-04. Applicant: Telesystems Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Telesystems 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
- Ormond Beach, FL, US
Recent devices under product code OAS
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