PIPER— 510(k) K001295
Substantially EquivalentRtek Medical Systems, LLC
FDA 510(k) clearance K001295 for PIPER, Substantially Equivalent on 2000-10-25. Applicant: Rtek Medical Systems, LLC. Device class: 2.
Clearance details
- Applicant
- Rtek Medical Systems, LLC
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsford, NY, US
Recent devices under product code MUJ
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