BIO-RAY SDX DIGITAL X-RAY SYSTEM— 510(k) K060179
Substantially EquivalentSigma Biomedics, Inc.
FDA 510(k) clearance K060179 for BIO-RAY SDX DIGITAL X-RAY SYSTEM, Substantially Equivalent on 2006-02-08. Applicant: Sigma Biomedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Biomedics, Inc.
- Product code
- Code MUH
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Prospect Heights, IL, US
Recent devices under product code MUH
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