DOT-A, DOT-AR PXP-E, PXP-ER— 510(k) K841905
Substantially EquivalentSiemens Gammasonics, Inc.
FDA 510(k) clearance K841905 for DOT-A, DOT-AR PXP-E, PXP-ER, Substantially Equivalent on 1984-08-09. Applicant: Siemens Gammasonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Gammasonics, Inc.
- Product code
- Code JWM
- Device class
- Class 2
- Regulation
- 21 CFR 892.1310
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code JWM
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