POLYSCAN DIGITAL SCANNER— 510(k) K882453
Substantially EquivalentMedical and Scientific Enterprises, Inc.
FDA 510(k) clearance K882453 for POLYSCAN DIGITAL SCANNER, Substantially Equivalent on 1988-11-23. Applicant: Medical and Scientific Enterprises, Inc.. Device class: 1.
Clearance details
- Applicant
- Medical and Scientific Enterprises, Inc.
- Product code
- Code IYW
- Device class
- Class 1
- Regulation
- 21 CFR 892.1300
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sudbury, MA, US
Recent devices under product code IYW
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