ACCULITE— 510(k) K872841
Substantially EquivalentMedical Alignment Systems
FDA 510(k) clearance K872841 for ACCULITE, Substantially Equivalent on 1987-08-12. Applicant: Medical Alignment Systems. Device class: 1.
Clearance details
- Applicant
- Medical Alignment Systems
- Product code
- Code IWE
- Device class
- Class 1
- Regulation
- 21 CFR 892.5780
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandy, UT, US
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