PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701— 510(k) K101858
Substantially EquivalentShanghai Chenguang Medical Technologies Co, Ltd.
FDA 510(k) clearance K101858 for PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701, Substantially Equivalent on 2010-07-14. Applicant: Shanghai Chenguang Medical Technologies Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai Chenguang Medical Technologies Co, Ltd.
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
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