SAMSUNG RAYPAX SYSTEM— 510(k) K991537
Substantially EquivalentSamsung Sds Co., Ltd.
FDA 510(k) clearance K991537 for SAMSUNG RAYPAX SYSTEM, Substantially Equivalent on 1999-07-06. Applicant: Samsung Sds Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Samsung Sds Co., Ltd.
- Product code
- Code LMD
- Device class
- Class 1
- Regulation
- 21 CFR 892.2020
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aubrey, TX, US
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