NEWTOM QR-DVT 9000— 510(k) K003787
Substantially EquivalentAperio Services, LLC
FDA 510(k) clearance K003787 for NEWTOM QR-DVT 9000, Substantially Equivalent on 2001-03-08. Applicant: Aperio Services, LLC. Device class: 2.
Clearance details
- Applicant
- Aperio Services, LLC
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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